Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & JohnsonLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 14, 2026, FDA's public records list Heartport with 24 510(k) clearances. The most recent is a 510(k) clearance dated May 5, 2000: DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAI….
| May 5, 2000 | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIPK994243 · DWF | 510(k) clearances |
| Apr 20, 1999 | QUICKDRAW VENOUS CANNULAK981995 · DWF | 510(k) clearances |
| Mar 23, 1999 | DIRECTFLOW ARTERIAL CANNULAK990772 · DWF | 510(k) clearances |
| Sep 4, 1998 | HEARTPORT ENDOPULMONARY VENT CATHETERK981009 · DWF | 510(k) clearances |
| Jul 15, 1998 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCERK974736 · DWF | 510(k) clearances |
| Dec 16, 1997 | HEARTPORT ENDOAORTIC CLAMP CATHETERK974175 · DWZ | 510(k) clearances |
| Oct 1, 1997 | HEARTPORT INTRODUCER SHEATHK972570 · DYB | 510(k) clearances |
| Jun 17, 1997 | HEARTPORT ENDOARTERIAL RETURN CANNULAK971291 · DWF | 510(k) clearances |
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