The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron Screen.
| Device ID | K952270 |
| 510k Number | K952270 |
| Device Name: | DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Contact | Sharon Thompson |
| Correspondent | Sharon Thompson SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-15 |
| Decision Date | 1995-08-21 |