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Arstasis

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

  • 510(k) clearances: 14

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Aug 7, 2015MicroTract Access SystemK151877 · DRE510(k) clearances
Jun 6, 2014AXERA 2 ACCESS SYSTEMK140871 · DYB510(k) clearances
May 16, 2014AXERA RX ACCESS SYSTEMK140287 · DYB510(k) clearances
Mar 28, 2014AXERA 2 ACCESS SYSTEMK140201 · DYB510(k) clearances
Aug 19, 2013AXERA 2 ACCESS SYSTEMK132263 · DYB510(k) clearances
Mar 24, 2013AXERA 2 ACCESS SYSTEMK123618 · DYB510(k) clearances
Jan 28, 2013AXERA 2 ACCESS SYSTEM MODEL AXE200K123135 · DYB510(k) clearances
Jun 21, 2012AXERA ACCESS SYSTEMK121521 · DYB510(k) clearances

Names and Identifiers

Appears as
Arstasis, 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

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