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 | K173586 |
| 510k Number | K173586 |
| Device Name: | VAMP Venous/Arterial Blood Management Protection System |
| Classification | Catheter, Continuous Flush |
| Applicant | Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92618 |
| Contact | Ye Seul Kim |
| Correspondent | Ye Seul Kim Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92618 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103001341 | K173586 | 000 |
| 07460691950566 | K173586 | 000 |
| 07460691950573 | K173586 | 000 |
| 07460691950597 | K173586 | 000 |
| 07460691950603 | K173586 | 000 |
| 07460691950610 | K173586 | 000 |
| 07460691951792 | K173586 | 000 |
| 07460691951808 | K173586 | 000 |
| 07460691957510 | K173586 | 000 |
| 07460691959415 | K173586 | 000 |
| 57460691959519 | K173586 | 000 |