The following data is part of a premarket notification filed by Edwards Lifesciences Llc with the FDA for Vamp Optima Closed Blood Sampling System.
| Device ID | K180275 |
| 510k Number | K180275 |
| Device Name: | VAMP Optima Closed Blood Sampling 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 |
| Subsequent Product Code | FMG |
| Subsequent Product Code | FPA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-31 |
| Decision Date | 2018-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50690103200213 | K180275 | 000 |
| 50690103198978 | K180275 | 000 |
| 00690103198980 | K180275 | 000 |
| 50690103198992 | K180275 | 000 |
| 50690103199005 | K180275 | 000 |
| 50690103199012 | K180275 | 000 |
| 50690103199067 | K180275 | 000 |
| 50690103199074 | K180275 | 000 |
| 00690103199086 | K180275 | 000 |
| 50690103199098 | K180275 | 000 |
| 00690103199154 | K180275 | 000 |
| 50690103199166 | K180275 | 000 |
| 50690103199173 | K180275 | 000 |
| 50690103199180 | K180275 | 000 |
| 50690103200206 | K180275 | 000 |
| 00690103198966 | K180275 | 000 |