The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Intersept* Cardiotomy Reservoir With Filter.
Device ID | K864895 |
510k Number | K864895 |
Device Name: | INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
Contact | James J Brennan |
Correspondent | James J Brennan JOHNSON & JOHNSON PROFESSIONALS, INC. P.O. BOX 386 King Of Prussia, PA 19406 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-15 |
Decision Date | 1987-02-19 |