510(k) K122545 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
| Applicant | Arrow International (Subsidiary of Teleflex Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Sep 20, 2012 |
| Received | Aug 21, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122545
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC;
AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB;
AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV;
AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DL Open, Classified |
LJS | None listed |
| Jan 29, 2015 | Arrow International Inc Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.