The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Sleek Otw Pta Catheter.
| Device ID | K130786 |
| 510k Number | K130786 |
| Device Name: | SLEEK OTW PTA CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | C.R. BARD, INC. MOYNE UPPER Enniscorthy, Co. Wexford, IE Ei |
| Contact | Fiona Ni Mhullain |
| Correspondent | Fiona Ni Mhullain C.R. BARD, INC. MOYNE UPPER Enniscorthy, Co. Wexford, IE Ei |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-21 |
| Decision Date | 2013-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741134036 | K130786 | 000 |
| 00801741133633 | K130786 | 000 |
| 00801741133640 | K130786 | 000 |
| 00801741133718 | K130786 | 000 |
| 00801741133725 | K130786 | 000 |
| 00801741133794 | K130786 | 000 |
| 00801741133800 | K130786 | 000 |
| 00801741133855 | K130786 | 000 |
| 00801741133862 | K130786 | 000 |
| 00801741133879 | K130786 | 000 |
| 00801741133886 | K130786 | 000 |
| 00801741133930 | K130786 | 000 |
| 00801741133947 | K130786 | 000 |
| 00801741133954 | K130786 | 000 |
| 00801741133961 | K130786 | 000 |
| 00801741134012 | K130786 | 000 |
| 00801741134029 | K130786 | 000 |
| 00801741133565 | K130786 | 000 |