The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Modification Of Carpentier-edwards Bioprosthesis.
| Device ID | K864155 |
| 510k Number | K864155 |
| Device Name: | MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS |
| Classification | Holder, Heart-valve, Prosthesis |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Sherrin Baky |
| Correspondent | Sherrin Baky AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | DTJ |
| CFR Regulation Number | 870.3935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-23 |
| Decision Date | 1986-11-20 |