510(k) K895268 ยท DQO Catheter, Intravascular, Diagnostic
ARROW HANDS-OFF THERMO-PACE
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Nov 6, 1989 |
| Received | Aug 23, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2016 | Arrow International Inc HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, ena Terminated |
DQO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.