The following data is part of a premarket notification filed by Trireme Medical Inc with the FDA for Glider Pta Balloon Catheter.
| Device ID | K101062 |
| 510k Number | K101062 |
| Device Name: | GLIDER PTA BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | TRIREME MEDICAL INC 7060 KNOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-04-16 |
| Decision Date | 2010-05-12 |
| Summary: | summary |