The following data is part of a premarket notification filed by Trireme Medical, Inc. with the FDA for Chocolate Pta Balloon Catheter (over The Wire) Guide Wire (0.014 And 0.018).
| Device ID | K111738 |
| 510k Number | K111738 |
| Device Name: | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014 AND 0.018) |
| Classification | Catheter, Percutaneous |
| Applicant | TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakami |
| Correspondent | Bhavesh V Sheth INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-21 |
| Decision Date | 2011-12-14 |
| Summary: | summary |