The following data is part of a premarket notification filed by Edwards Lifesciences, Llc. with the FDA for Edwards Bovine Pericardial Patch, Model 4700.
Device ID | K082139 |
510k Number | K082139 |
Device Name: | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 |
Classification | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene |
Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
Contact | Daryl Richardson |
Correspondent | Daryl Richardson EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY Irvine, CA 92614 |
Product Code | DXZ |
CFR Regulation Number | 870.3470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-07-29 |
Decision Date | 2008-10-23 |
Summary: | summary |