The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Lifesciences Endoclamp Aortic Catheter.
| Device ID | K112694 |
| 510k Number | K112694 |
| Device Name: | EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER |
| Classification | Clamp, Vascular |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Spencer Walker |
| Correspondent | Spencer Walker EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-15 |
| Decision Date | 2011-10-14 |
| Summary: | summary |