The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Quickcat Extraction Catheter, Model 60090-01.
Device ID | K073519 |
510k Number | K073519 |
Device Name: | QUICKCAT EXTRACTION CATHETER, MODEL 60090-01 |
Classification | Catheter, Embolectomy |
Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
Contact | Cindy Varughese |
Correspondent | Cindy Varughese KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-14 |
Decision Date | 2008-03-28 |
Summary: | summary |