The following data is part of a premarket notification filed by Inari Medical with the FDA for Retraction Aspirator.
Device ID | K152097 |
510k Number | K152097 |
Device Name: | Retraction Aspirator |
Classification | Catheter, Embolectomy |
Applicant | INARI MEDICAL 9272 JERONIMO RD., SUITE 124 Irvine, CA 92618 |
Contact | Eben Gordon |
Correspondent | Eben Gordon INARI MEDICAL 9272 JERONIMO RD., SUITE 124 Irvine, CA 92618 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-28 |
Decision Date | 2015-08-25 |
Summary: | summary |