The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Reverse Medical Micro Vascular Plug (mvp) System.
Device ID | K133282 |
510k Number | K133282 |
Device Name: | REVERSE MEDICAL MICRO VASCULAR PLUG (MVP) SYSTEM |
Classification | Device, Vascular, For Promoting Embolization |
Applicant | REVERSE MEDICAL CORPORATION 13700 Alton Parkway Suite 167 Irvine, CA 92618 |
Contact | Jeffrey Valko |
Correspondent | Jeffrey Valko REVERSE MEDICAL CORPORATION 13700 Alton Parkway Suite 167 Irvine, CA 92618 |
Product Code | KRD |
CFR Regulation Number | 870.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-25 |
Decision Date | 2013-11-27 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00847536003835 | K133282 | 000 |
00847536003606 | K133282 | 000 |