510(k) K003006 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Oct 27, 2000 |
| Received | Sep 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PICC ACCESS TRAY/ASK-04001-CG1 Open, Classified |
LJT | None listed |
| Sep 30, 2015 | Arrow International Inc Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Terminated |
FOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.