The following data is part of a premarket notification filed by Trireme Medical, Llc with the FDA for Chocolate Ptca Balloon Catheter.
| Device ID | K150292 |
| 510k Number | K150292 |
| Device Name: | Chocolate PTCA Balloon Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | TRIREME MEDICAL, LLC 7060 KOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 95466 |
| Contact | Shiva Ardakani |
| Correspondent | Shiva Ardakani TRIREME MEDICAL, LLC 7060 KOLL CENTER PARKWAY SUITE 300 Pleasanton, CA 95466 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-06 |
| Decision Date | 2015-04-09 |
| Summary: | summary |