The following data is part of a premarket notification filed by Ev3 Inc. with the FDA for Modification To: Nanocross 0.14 Otw Pta Dilatation Catheter, Models Ab14w020210090, Ab14w020210150.
| Device ID | K090849 |
| 510k Number | K090849 |
| Device Name: | MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 |
| Classification | Catheter, Percutaneous |
| Applicant | EV3 INC. 9600 54TH AVE NORTH Plymouth, MN 55442 |
| Contact | Sara Bakkar |
| Correspondent | Sara Bakkar EV3 INC. 9600 54TH AVE NORTH Plymouth, MN 55442 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-05-01 |
| Summary: | summary |