The following data is part of a premarket notification filed by Trireme Medical Inc with the FDA for Chocolate Pta Ballon Catheter (over The Wire) Guide Wire (0.014).
| Device ID | K120677 |
| 510k Number | K120677 |
| Device Name: | CHOCOLATE PTA BALLON CATHETER (OVER THE WIRE) GUIDE WIRE (0.014) |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-03-06 |
| Decision Date | 2012-03-15 |
| Summary: | summary |