510(k) K923311
K923311 is an FDA 510(k) premarket notification submitted by 3M Health Care, Sarns for the device "CONDUCER HEAT EXCHANGER". The FDA issued a decision of Substantially Equivalent on September 18, 1992. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. 3M Health Care, Sarns has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1992
- Date Received
- July 7, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heat-Exchanger, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4240
- Review Panel
- CV
- Submission Type