The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Peripheral Dilation Catheter.
| Device ID | K052149 |
| 510k Number | K052149 |
| Device Name: | EDWARDS PERIPHERAL DILATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Kevin Drisko |
| Correspondent | Kevin Drisko EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-08 |
| Decision Date | 2005-09-02 |
| Summary: | summary |