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 |