The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Embol-x Access Device/ Aortic Cannula, Embol-x Slim Accessdevice/ Aortic Cannula, Embol-x Glide Access Device/ Aortic Ca.
| Device ID | K102420 |
| 510k Number | K102420 |
| Device Name: | EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Contact | Dannette Crooms |
| Correspondent | Dannette Crooms EDWARDS LIFESCIENCES, LLC. 12050 Lone Peak Pkwy Draper, UT 84020 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-25 |
| Decision Date | 2010-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103170269 | K102420 | 000 |