The following data is part of a premarket notification filed by Clear Stream Technologies, Ltd. with the FDA for Bantam,48xxxxxx, 50xxxxxx.
| Device ID | K093139 |
| 510k Number | K093139 |
| Device Name: | BANTAM,48XXXXXX, 50XXXXXX |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CLEAR STREAM TECHNOLOGIES, LTD. MOYNE UPPER, ENNISCORTHY Enniscorthy, IE |
| Contact | Fiona Ni Mhullain |
| Correspondent | Fiona Ni Mhullain CLEAR STREAM TECHNOLOGIES, LTD. MOYNE UPPER, ENNISCORTHY Enniscorthy, IE |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2009-12-30 |
| Summary: | summary |