The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Carotid Bypass Shunt.
Device ID | K860742 |
510k Number | K860742 |
Device Name: | CAROTID BYPASS SHUNT |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
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 | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-27 |
Decision Date | 1986-05-28 |