The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Fogarty Occlusion Catheter.
| Device ID | K093911 |
| 510k Number | K093911 |
| Device Name: | FOGARTY OCCLUSION CATHETER |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Patricia A Milbank |
| Correspondent | Patricia A Milbank EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103043754 | K093911 | 000 |
| 00690103043747 | K093911 | 000 |
| 00690103043730 | K093911 | 000 |
| 00690103043723 | K093911 | 000 |
| 00690103043716 | K093911 | 000 |