510(k) K994243 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP
| Applicant | Heartport, Inc., Redwood City CA, US |
| Decision | Substantially Equivalent, May 5, 2000 |
| Received | Dec 16, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K994243
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.