510(k) K811627 ยท GBW Catheter, Peritoneal
ARROW PERITONEAL LAVAGE CATHERIZATION K
| Applicant | Arrow Intl., Inc., Walker MI, US |
| Decision | Substantially Equivalent, Aug 10, 1981 |
| Received | Jun 9, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K811627
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PERITONEAL LAVAGE CATH KIT:8FR/AK-09000 Open, Classified |
GBW | None listed |
| Aug 25, 2004 | Arrow International Inc Peritoneal Lavage Kits, Model number AK-09000 Terminated |
GBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.