The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Flow Rider Flow Directed Micro Catheter.
| Device ID | K980104 |
| 510k Number | K980104 |
| Device Name: | FLOW RIDER FLOW DIRECTED MICRO CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Contact | Tom Daughters |
| Correspondent | Tom Daughters MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-12 |
| Decision Date | 1998-04-10 |
| Summary: | summary |