The following data is part of a premarket notification filed by Fox Hollow Technologies with the FDA for The Rinspirator, Models Fg09770, Fg08776, Fg08777, Fg08910.
| Device ID | K071826 |
| 510k Number | K071826 |
| Device Name: | THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 |
| Classification | Catheter, Embolectomy |
| Applicant | FOX HOLLOW TECHNOLOGIES 740 BAY ROAD Redwood City, CA 94063 |
| Contact | Sridevi Sheshadri |
| Correspondent | Sridevi Sheshadri FOX HOLLOW TECHNOLOGIES 740 BAY ROAD Redwood City, CA 94063 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-03 |
| Decision Date | 2007-11-09 |
| Summary: | summary |