The following data is part of a premarket notification filed by Usci Ireland with the FDA for Optimus 0.035 Pta Balloon Dilatation Catheter.
| Device ID | K082646 |
| 510k Number | K082646 |
| Device Name: | OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | USCI IRELAND 5 TIMBER LANE North Reading, MA 01864 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell USCI IRELAND 5 TIMBER LANE North Reading, MA 01864 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-11 |
| Decision Date | 2008-11-03 |
| Summary: | summary |