The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Truline Reinforced Valved Infusion Catheter.
| Device ID | K021139 |
| 510k Number | K021139 |
| Device Name: | TRULINE REINFORCED VALVED INFUSION CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Contact | Tom Daughters |
| Correspondent | Tom Daughters MICRO THERAPEUTICS, INC. 2 GOODYEAR Irvine, CA 92618 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-09 |
| Decision Date | 2002-04-17 |
| Summary: | summary |