510(k) K962726
K962726 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD QUANTUM CVR". The FDA issued a decision of Substantially Equivalent on Oct 30, 1996. The device falls under product code DTP (Defoamer, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4230. C.R. Bard, Inc. has 645 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 30, 1996
- Date Received
- Jul 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Defoamer, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4230
- Review Panel
- CV
- Submission Type
- 510(k)