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) 0.014 Guide Wire Chocolate Pta Balloon Catheter (over The Wire) 0.018' G.
| Device ID | K121402 |
| 510k Number | K121402 |
| Device Name: | CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.018' G |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | Shiva Ardakani TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-10 |
| Decision Date | 2012-06-08 |
| Summary: | summary |