The following data is part of a premarket notification filed by Clearstream Technologies, Ltd. with the FDA for Reeflex Pta Catheter.
| Device ID | K101361 |
| 510k Number | K101361 |
| Device Name: | REEFLEX PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CLEARSTREAM TECHNOLOGIES, LTD. MOYNE UPPER Enniscorthy, County Wexford, IE |
| Contact | Fiona N Mhullain |
| Correspondent | Fiona N Mhullain CLEARSTREAM TECHNOLOGIES, LTD. MOYNE UPPER Enniscorthy, County Wexford, IE |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-14 |
| Decision Date | 2010-08-04 |
| Summary: | summary |