510(k) K042126 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PICC
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Unknown, Aug 27, 2004 |
| Received | Aug 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042126
| 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 |
| Sep 30, 2015 | Arrow International Inc Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes Terminated |
FOZ | None listed |
| Aug 25, 2015 | Arrow International Inc PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound
Product Usage:
catheter, intravascular, therapeutic, ultrasound Terminated |
LJS | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Peripherally Inserted Central Catheter Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.