The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Transfemoral Balloon Catheter.
| Device ID | K140241 |
| 510k Number | K140241 |
| Device Name: | EDWARDS TRANSFEMORAL BALLOON CATHETER |
| Classification | Balloon Aortic Valvuloplasty |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92663 |
| Contact | Eric Carrier |
| Correspondent | Eric Carrier EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92663 |
| Product Code | OZT |
| CFR Regulation Number | 870.1255 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-30 |
| Decision Date | 2014-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103193459 | K140241 | 000 |
| 00690103191820 | K140241 | 000 |
| 00690103191813 | K140241 | 000 |