510(k) K153423 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
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| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Jan 28, 2016 |
| Received | Nov 25, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153423
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.