The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Titan Micro Catheter, Model 105-5074-153; Hd Injector, Model 103-0305.
| Device ID | K022003 |
| 510k Number | K022003 |
| Device Name: | TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 |
| Classification | Introducer, Catheter |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Bill Hyatt |
| Correspondent | Bill Hyatt MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-19 |
| Decision Date | 2002-09-13 |
| Summary: | summary |