510(k) K121941 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
ARROW PICC POWERED BY ARROW VPS STYLET
| Applicant | Arrow International (Subsidiary of Teleflex Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Sep 7, 2012 |
| Received | Jul 2, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter Open, Classified |
LJS | None listed |
| Oct 17, 2017 | Arrow International Inc ARROW PICC
powered by ARROW VPS
Stylet Terminated |
LJS | None listed |
| Jul 25, 2017 | Arrow International Inc ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter Terminated |
LJS | None listed |
| Jun 1, 2017 | Arrow International Inc ARROW PICC powered by ARROW VPS Stylet
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion Terminated |
LJS | None listed |
| Jun 1, 2017 | Arrow International Inc ARROW PICC powered by ARROW VPS Stylet
The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion 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 |
| 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 |
| 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 |
| 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 |
| Apr 24, 2014 | Arrow International Inc Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, 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.