510(k) K001822
K001822 is an FDA 510(k) premarket notification submitted by Circulatory Technology, Inc. for the device "THE V-BAG". The FDA issued a decision of Substantially Equivalent on July 7, 2000. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Circulatory Technology, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2000
- Date Received
- June 16, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reservoir, Blood, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4400
- Review Panel
- CV
- Submission Type