The following data is part of a premarket notification filed by Clear Stream Technologies, Ltd. with the FDA for Litepac, Model 682.
| Device ID | K100490 |
| 510k Number | K100490 |
| Device Name: | LITEPAC, MODEL 682 |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CLEAR STREAM TECHNOLOGIES, LTD. MOYNE UPPER, ENNISCORTHY County Wexford, IE |
| Contact | Fiona Ni Mhullain |
| Correspondent | Fiona Ni Mhullain CLEAR STREAM TECHNOLOGIES, LTD. MOYNE UPPER, ENNISCORTHY County Wexford, IE |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-19 |
| Decision Date | 2010-03-16 |
| Summary: | summary |