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Arrow International

Medical device maker in United States, part of Teleflex. FDA records under 17 spellings of its name, each linked to the record.

  • Device recalls: 534
  • 510(k) clearances: 156
  • Drug applications: 1

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Mar 26, 2025AC3™ Range™ Intra-Aortic Balloon PumpK250542 · DSP510(k) clearances
Mar 14, 2025Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)K243599 · FOZ510(k) clearances
Dec 20, 2024Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00622); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00820); Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00822)K242281 · FOZ510(k) clearances
Aug 30, 2023AC3™ Series IABPK232343 · DSP510(k) clearances
Feb 13, 2023Arrow 0.2 Micron Flat Filter, GVSK222341 · CAZ510(k) clearances
Sep 2, 2022Arrow Pressure Injectable Midline CatheterK213855 · PND510(k) clearances
Aug 30, 2022Arrow Stiffening StyletK220280 · DRB510(k) clearances
Aug 22, 2022VPS Rhythm DLX Device with TipTracker TechnologyK220363 · LJS510(k) clearances
Feb 10, 2016Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the Class I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls
Feb 10, 2016Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aortClass I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls
Feb 10, 2016Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aortClass I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls
Feb 10, 2016RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aortClass I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls
Feb 10, 2016UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the Class I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls
Feb 10, 2016FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloClass I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls
Feb 10, 2016UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the Class I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls
Feb 10, 2016Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aClass I · The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding frDevice recalls

Canada and Imports

Matched by company name
Active Health Canada device licences
80, as of Nov 10, 2026

Names and Identifiers

Appears as
Arrow International IncArrow Intl., Inc.ARROW INTERNATIONAL, LLCARROW INTERNATIONAL Inc.Arrow International, Inc.Arrow International, Inc., Division of Teleflex Medical Inc.Arrow International, Inc. (Subsidiary of Teleflex, Inc.)Arrow International (Subsidiary of Teleflex Inc.)Arrow International, LLC (A subsidiary of Teleflex, Inc.)Arrow International, LLCArrow Int'L.Arrow International (A Subsidiary of Teleflex, Inc.)Arrow International, Inc. (A Subsidiary of Teleflex, Inc.)Arrow International, Inc. (Subsidiary of Telelflex Inc.)Arrow International, LLC Subsidiary of Teleflex IncorporatedARROW INTLArrow Internation, Inc. (Subsidiary of Teleflex Inc.)

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.