The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Intersept* Blood Filter W/ Tubing Bypass.
Device ID | K790435 |
510k Number | K790435 |
Device Name: | INTERSEPT* BLOOD FILTER W/ TUBING BYPASS |
Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
Applicant | SURGIKOS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DTM |
CFR Regulation Number | 870.4260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-13 |
Decision Date | 1979-03-27 |