510(k) K181684 ยท KRA Catheter, Continuous Flush
VAMP Plus Venous/Arterial Blood Management Protection System
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 8, 2018 |
| Received | Jun 26, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181684
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.