The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Ultraflow Hpc Flow Directed Micro Catheter, Models 105-5065 And 105-5066.
| Device ID | K024118 |
| 510k Number | K024118 |
| Device Name: | ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, MODELS 105-5065 AND 105-5066 |
| Classification | Catheter, Continuous Flush |
| 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 | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-02-03 |
| Summary: | summary |