The following data is part of a premarket notification filed by Edwards Laboratories with the FDA for Filter (7220&7221 Mobin-uddin Vena Cava).
Device ID | K760152 |
510k Number | K760152 |
Device Name: | FILTER (7220&7221 MOBIN-UDDIN VENA CAVA) |
Classification | Filter, Intravascular, Cardiovascular |
Applicant | EDWARDS LABORATORIES 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DTK |
CFR Regulation Number | 870.3375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-07-01 |
Decision Date | 1976-07-19 |