The following data is part of a premarket notification filed by Trireme Medical Inc with the FDA for Glider Ptca Balloon Catheter.
| Device ID | K111544 |
| 510k Number | K111544 |
| Device Name: | GLIDER PTCA BALLOON CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | Shiva Ardakani TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-03 |
| Decision Date | 2012-03-02 |
| Summary: | summary |