510(k) K812243
K812243 is an FDA 510(k) premarket notification submitted by Medical, Inc. for the device "INTERFACE CARDIOTOMY BLOOD FILTER #51". The FDA issued a decision of Substantially Equivalent on August 25, 1981. The device falls under product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4270. Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 1981
- Date Received
- August 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4270
- Review Panel
- CV
- Submission Type