510(k) K830634
K830634 is an FDA 510(k) premarket notification submitted by Texas Medical Products, Inc. for the device "CARDIOTOMY FILTER". The FDA issued a decision of Substantially Equivalent on June 30, 1983. The device falls under product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4270. Texas Medical Products, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1983
- Date Received
- March 1, 1983
- 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