510(k) K103255 ยท OBJ Catheter, Ultrasound, Intravascular
VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET
| Applicant | Vasonova, Inc., Menlo Park CA, US |
| Decision | Substantially Equivalent, Feb 18, 2011 |
| Received | Nov 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2017 | Arrow International Inc Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter
The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market availa Terminated |
OBJ | None listed |
| Apr 28, 2017 | Arrow International Inc Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters Terminated |
OBJ | 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.