The following data is part of a premarket notification filed by Reverse Medical Corporation with the FDA for Recruit Microcatheter.
Device ID | K091563 |
510k Number | K091563 |
Device Name: | RECRUIT MICROCATHETER |
Classification | Device, Percutaneous Retrieval |
Applicant | REVERSE MEDICAL CORPORATION 13700 ALTON PARKWAY SUITE 167 Irvine, CA 92618 |
Contact | Amy Eskina |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | MMX |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2009-05-28 |
Decision Date | 2009-07-30 |
Summary: | summary |