The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Affinity Cp Centrifugal Blood Pump With Balance Biosurface.
Device ID | K111657 |
510k Number | K111657 |
Device Name: | AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE |
Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
Applicant | MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Contact | Lisa Stone |
Correspondent | Lisa Stone MEDTRONIC, INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Product Code | KFM |
CFR Regulation Number | 870.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2011-06-14 |
Decision Date | 2011-06-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20613994647850 | K111657 | 000 |