The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Pruitt-inahara Carotid Shunt 400-40-8f/inahara-pruitt Carotid Shunt 500-50-8f.
| Device ID | K960715 |
| 510k Number | K960715 |
| Device Name: | PRUITT-INAHARA CAROTID SHUNT 400-40-8F/INAHARA-PRUITT CAROTID SHUNT 500-50-8F |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Elizabeth M Paul |
| Correspondent | Elizabeth M Paul IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-21 |
| Decision Date | 1996-09-09 |
| Summary: | summary |