The following data is part of a premarket notification filed by Sorin Biomedical, Inc. with the FDA for Dideco Newborn/infant Arterial Filters: D735 Micro 20 And D736 Micro 40.
| Device ID | K961869 |
| 510k Number | K961869 |
| Device Name: | DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | SORIN BIOMEDICAL, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92713 -9503 |
| Contact | Susan J Reimers |
| Correspondent | Susan J Reimers 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 | 1996-05-15 |
| Decision Date | 1996-08-12 |