The following data is part of a premarket notification filed by Edwards Lifesciences Llc with the FDA for Vamp Venous/arterial Blood Management Protection System.
| Device ID | K161962 |
| 510k Number | K161962 |
| Device Name: | VAMP Venous/Arterial Blood Management Protection System |
| Classification | Catheter, Continuous Flush |
| Applicant | Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Contact | Jennifer Wilbur |
| Correspondent | Jennifer Wilbur Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-18 |
| Decision Date | 2016-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50690103200299 | K161962 | 000 |
| 50690103206291 | K161962 | 000 |
| 50690103198237 | K161962 | 000 |
| 50690103200336 | K161962 | 000 |