The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Embolectomy Catheter.
Device ID | K902327 |
510k Number | K902327 |
Device Name: | EMBOLECTOMY CATHETER |
Classification | Catheter, Embolectomy |
Applicant | CLINCAL INSTRUMENTS CORP. 9 CROSS ST. Dudley, MA 01570 |
Contact | Michael L Polanyi |
Correspondent | Michael L Polanyi CLINCAL INSTRUMENTS CORP. 9 CROSS ST. Dudley, MA 01570 |
Product Code | DXE |
CFR Regulation Number | 870.5150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-24 |
Decision Date | 1991-02-25 |