The following data is part of a premarket notification filed by Clear Stream Technologies, Ltd. with the FDA for Sleek Otw Pta Catheters.
| Device ID | K102035 |
| 510k Number | K102035 |
| Device Name: | SLEEK OTW PTA CATHETERS |
| 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 | 2010-07-19 |
| Decision Date | 2010-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741134005 | K102035 | 000 |
| 00801741133688 | K102035 | 000 |
| 00801741133671 | K102035 | 000 |
| 00801741133664 | K102035 | 000 |
| 00801741133657 | K102035 | 000 |
| 00801741133626 | K102035 | 000 |
| 00801741133619 | K102035 | 000 |
| 00801741133602 | K102035 | 000 |
| 00801741133596 | K102035 | 000 |
| 00801741133589 | K102035 | 000 |
| 00801741133572 | K102035 | 000 |
| 00801741133558 | K102035 | 000 |
| 00801741133541 | K102035 | 000 |
| 00801741133534 | K102035 | 000 |
| 00801741133527 | K102035 | 000 |
| 00801741133510 | K102035 | 000 |
| 00801741133503 | K102035 | 000 |
| 00801741133695 | K102035 | 000 |
| 00801741133701 | K102035 | 000 |
| 00801741133732 | K102035 | 000 |
| 00801741133992 | K102035 | 000 |
| 00801741133985 | K102035 | 000 |
| 00801741133978 | K102035 | 000 |
| 00801741133923 | K102035 | 000 |
| 00801741133916 | K102035 | 000 |
| 00801741133909 | K102035 | 000 |
| 00801741133893 | K102035 | 000 |
| 00801741133848 | K102035 | 000 |
| 00801741133831 | K102035 | 000 |
| 00801741133824 | K102035 | 000 |
| 00801741133817 | K102035 | 000 |
| 00801741133787 | K102035 | 000 |
| 00801741133770 | K102035 | 000 |
| 00801741133763 | K102035 | 000 |
| 00801741133756 | K102035 | 000 |
| 00801741133749 | K102035 | 000 |
| 00801741133497 | K102035 | 000 |