The following data is part of a premarket notification filed by Trireme Medical, Inc. with the FDA for Gliderxtreme Pta Ballon Catheter (over The Wire) 0.018 Guide Wire 6100-xxxxx, 6100cb-xxxx.
| Device ID | K112281 |
| 510k Number | K112281 |
| Device Name: | GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX |
| Classification | Catheter, Percutaneous |
| Applicant | TRIREME MEDICAL, INC. 7060 Koll 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-09 |
| Decision Date | 2011-08-17 |
| Summary: | summary |