The following data is part of a premarket notification filed by Trireme Medical, Inc. with the FDA for Gliderxtreme Pta Balloon Catheter (cb) (over The Wire) 0.014 / 0.018 Guide Wire.
| Device ID | K103534 |
| 510k Number | K103534 |
| Device Name: | GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE |
| Classification | Catheter, Percutaneous |
| Applicant | TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-12-01 |
| Decision Date | 2011-01-05 |
| Summary: | summary |