The following data is part of a premarket notification filed by Sterile Design, Inc. with the FDA for Cardio Metrics Cardiotomy Reservoir.
Device ID | K841958 |
510k Number | K841958 |
Device Name: | CARDIO METRICS CARDIOTOMY RESERVOIR |
Classification | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
Applicant | STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar, FL 34677 -0137 |
Contact | John C Hoffman |
Correspondent | John C Hoffman STERILE DESIGN, INC. P.O. BOX 12100 Oldsmar, FL 34677 -0137 |
Product Code | JOD |
CFR Regulation Number | 870.4270 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-05-14 |
Decision Date | 1984-10-15 |