510(k) K113277 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS
| Applicant | Arrow International, Inc., Reading PA, US |
| Decision | Substantially Equivalent, Jun 21, 2012 |
| Received | Nov 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113277
| 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 |
| Dec 20, 2019 | Arrow International Inc PICC Set- PR-35052-HPHNM Terminated |
LJS | None listed |
| Apr 11, 2018 | Arrow International Inc ARROW PICC Set; Product codes: PR-34052-HPHNM, PR-34063-HPHNM, PR-35041-HPHNM, PR-35052-HPHNM, PR-35541-HPHNL, PR-35541-HPHNM, PR-35552-HPHNL, PR-35552-HPHNM Terminated |
LJS | None listed |
| Jul 25, 2017 | Arrow International Inc ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A. Terminated |
LJS | None listed |
| Jun 1, 2017 | Arrow International Inc ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC)
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for i Terminated |
LJS | None listed |
| Nov 4, 2015 | Arrow International Inc ARROW PICC Kit featuring Chlorag+ard Technology
Midline Catheterization Kit
ARROW Advantage5 Pressure Injectable PICC Kit
Arrow Pressure Injectable Arrow PICC powered by Arrow VPS Stylet
ARROW Pressur Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.