The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Needle's Eye Snare Retrieval Set - 54cm.
Device ID | K163353 |
510k Number | K163353 |
Device Name: | Needle's Eye Snare Retrieval Set - 54cm |
Classification | Catheter, Embolectomy |
Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
Contact | Thomas Kardos |
Correspondent | Thomas Kardos Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-30 |
Decision Date | 2017-07-11 |
Summary: | summary |