510(k) K130876 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
CG+ ARROW PICC POWERED BY ARROW VPS STYLET
| Applicant | Arrow International, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Apr 26, 2013 |
| Received | Mar 29, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130876
| 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 |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance PICC pre loaded
with Arrow VPS" Precision Stylet
Product Code: CDC 45063 HPK1A Terminated |
LJS | None listed |
| Apr 11, 2018 | Arrow International Inc Arrow PICC with Chlorag+ard Technology; Product codes: PR-44041-BAS, PR-44052-BAS, PR-44063-BAS, PR-45041-BAS, PR-45052-BAS, PR-45063-BAS, PR-45541-BAS,PR-45541-HPHNL, PR-45541-HPHNM, PR-45552-BAS, P Terminated |
LJS | None listed |
| Aug 31, 2015 | Arrow International Inc Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days Terminated |
OBJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.