The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for Vamp Plus Venous/arterial Blood Management Protection System.
| Device ID | K181684 |
| 510k Number | K181684 |
| Device Name: | VAMP Plus Venous/Arterial Blood Management Protection System |
| Classification | Catheter, Continuous Flush |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 |
| Contact | Ye Seul Kim |
| Correspondent | Ye Seul Kim 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 | 2018-06-26 |
| Decision Date | 2018-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07460691958616 | K181684 | 000 |
| 07460691944831 | K181684 | 000 |
| 07460691944824 | K181684 | 000 |
| 57460691959496 | K181684 | 000 |
| 57460691959489 | K181684 | 000 |
| 57460691959472 | K181684 | 000 |
| 50690103197124 | K181684 | 000 |