510(k) K973472
K973472 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "3M CDI H/S CUVETTES WITH HEPARON TREATMENT". The FDA issued a decision of Substantially Equivalent on December 8, 1997. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. 3M Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1997
- Date Received
- September 12, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4330
- Review Panel
- CV
- Submission Type