The following data is part of a premarket notification filed by Medtronic Blood Systems, Inc. with the FDA for Intersept*prebypass Filter.
Device ID | K883086 |
510k Number | K883086 |
Device Name: | INTERSEPT*PREBYPASS FILTER |
Classification | Filter, Prebypass, Cardiopulmonary Bypass |
Applicant | MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Contact | Dennie W Dyer |
Correspondent | Dennie W Dyer MEDTRONIC BLOOD SYSTEMS, INC. 4633 E. LA PALMA AVE. Anaheim, CA 92807 |
Product Code | KRJ |
CFR Regulation Number | 870.4280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-21 |
Decision Date | 1988-09-16 |