The following data is part of a premarket notification filed by Micro Therapeutics, Inc. with the FDA for Thrombolytic Brush Catheter, Over The Wire (otw).
| Device ID | K973669 |
| 510k Number | K973669 |
| Device Name: | THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) |
| Classification | Catheter, Peripheral, Atherectomy |
| Applicant | MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Contact | Brain Strauss |
| Correspondent | Brain Strauss MICRO THERAPEUTICS, INC. 1062-F CALLE NEGOCIO San Clemente, CA 92673 |
| Product Code | MCW |
| CFR Regulation Number | 870.4875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-25 |
| Decision Date | 1998-02-06 |
| Summary: | summary |