The following data is part of a premarket notification filed by Imodex, Inc. with the FDA for Carotid Balloon Shunt.
| Device ID | K860497 |
| 510k Number | K860497 |
| Device Name: | CAROTID BALLOON SHUNT |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | IMODEX, INC. 29001 HARPER AVE STE 5 St. Clair Shores, MI 48081 |
| Contact | Sheldon Davis |
| Correspondent | Sheldon Davis IMODEX, INC. 29001 HARPER AVE STE 5 St. Clair Shores, MI 48081 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-10 |
| Decision Date | 1986-05-28 |