510(k) K964017
K964017 is an FDA 510(k) premarket notification submitted by Avecor Cardiovascular, Inc. for the device "AFFINITY BLOOD PUMP SYSTEM". The FDA issued a decision of Substantially Equivalent on August 5, 1997. The device falls under product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4220. Avecor Cardiovascular, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1997
- Date Received
- October 7, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4220
- Review Panel
- CV
- Submission Type