510(k) K896819 ยท KRA Catheter, Continuous Flush
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Jan 19, 1990 |
| Received | Dec 4, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896819
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2023 | Edwards Lifesciences, LLC TruWave with Vamp System Pressure monitoring set,
REF: PXAVMP(3cc)/VAMP 68 in (173cm)
PXAVMP3: x3 (3cc)/VAMP
PXVK0364:(3cc)/VAMP 96in (241cm);
PXVK0853: x3 (3cc)/VAMP 76in (193cm);
PXVK0996:(3cc)/VAM Open, Classified |
DRS | None listed |
| Apr 18, 2013 | Edwards Lifesciences, LLC Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2.
B Terminated |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.