The following data is part of a premarket notification filed by Trireme Medical, Inc. with the FDA for Glider Ptca Balloon Catheter.
| Device ID | K121681 |
| 510k Number | K121681 |
| Device Name: | GLIDER PTCA BALLOON CATHETER |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566 |
| Contact | Shiva Ardakani |
| Correspondent | Shiva Ardakani TRIREME MEDICAL, INC. 7060 Koll Center Parkway Suite 300 Pleasanton, CA 94566 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-07 |
| Decision Date | 2012-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M8744100A35201 | K121681 | 000 |
| M8744100A25041 | K121681 | 000 |
| M8744100A20201 | K121681 | 000 |
| M8744100A20121 | K121681 | 000 |
| M8744100A20081 | K121681 | 000 |
| M8744100A20041 | K121681 | 000 |
| M8744100A15201 | K121681 | 000 |
| M8744100A15121 | K121681 | 000 |
| M8744100A15081 | K121681 | 000 |
| M8744100A25081 | K121681 | 000 |
| M8744100A25121 | K121681 | 000 |
| M8744100A35121 | K121681 | 000 |
| M8744100A35081 | K121681 | 000 |
| M8744100A35041 | K121681 | 000 |
| M8744100A30201 | K121681 | 000 |
| M8744100A30121 | K121681 | 000 |
| M8744100A30081 | K121681 | 000 |
| M8744100A30041 | K121681 | 000 |
| M8744100A25201 | K121681 | 000 |
| M8744100A15041 | K121681 | 000 |