The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Advance 14lp Low Profile Pta Balloon Dilatation Catheter.
| Device ID | K170193 |
| 510k Number | K170193 |
| Device Name: | Advance 14LP Low Profile PTA Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Daniel J. Corbin |
| Correspondent | Daniel J. Corbin COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-23 |
| Decision Date | 2017-02-13 |
| Summary: | summary |