510(k) K894268
K894268 is an FDA 510(k) premarket notification submitted by Medi-Sharp, Inc. for the device "C.A.B. RING". The FDA issued a decision of Substantially Equivalent on August 17, 1989. The device falls under product code MAB (Marker, Cardiopulmonary Bypass (Vein Marker)), a Class II device regulated under 21 CFR 870.3450.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1989
- Date Received
- June 22, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Cardiopulmonary Bypass (Vein Marker)
- Device Class
- Class II
- Regulation Number
- 870.3450
- Review Panel
- CV
- Submission Type