510(k) K153487 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
| Applicant | Arrow International, Inc. (Subsidiary of Teleflex, Inc.), Reading PA, US |
| Decision | Substantially Equivalent, Feb 4, 2016 |
| Received | Dec 4, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153487
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2023 | ARROW INTERNATIONAL Inc. Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Cath 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 44063 VPS2 Terminated |
LJS | None listed |
| Apr 23, 2019 | Arrow International Inc Arrowg+ard Blue Advance" PICC pre loaded with Arrow VPS" Precision Stylet
Product Code: CDC 45041 VPS2 Terminated |
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 VPS2 Terminated |
LJS | None listed |
| Dec 13, 2018 | Arrow International Inc Arrow PICC powered by Arrow VPS Precision Stylet
Product Code:CDC-45052-VPS2
Product Usage:
The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central Terminated |
LJS | None listed |
| Dec 13, 2018 | Arrow International Inc Arrow PICC powered by Arrow VPS Precision Stylet
Product Code:CDC-44052-VPS2
Product Usage:
The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central Terminated |
LJS | None listed |
| Jul 17, 2018 | Arrow International Inc 4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2 Terminated |
LJS | None listed |
| Jul 17, 2018 | Arrow International Inc 5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2 Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.