The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Carotid Bypass Shunt With Sampling Arm.
| Device ID | K860743 |
| 510k Number | K860743 |
| Device Name: | CAROTID BYPASS SHUNT WITH SAMPLING ARM |
| 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 |