The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Fogarty Occlusion Catheter.
| Device ID | K152762 |
| 510k Number | K152762 |
| Device Name: | Fogarty Occlusion Catheter |
| Classification | Catheter, Intravascular Occluding, Temporary |
| Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Contact | Naren Murugan |
| Correspondent | Naren Murugan EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
| Product Code | MJN |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-24 |
| Decision Date | 2015-11-23 |
| Summary: | summary |