510(k) K864703
K864703 is an FDA 510(k) premarket notification submitted by Cardiovascular Devices, Inc. for the device "MODIFIED GAS-STAT(TM) MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on February 19, 1987. The device falls under product code DTY (Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4410. Cardiovascular Devices, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1987
- Date Received
- December 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- Device Class
- Class II
- Regulation Number
- 870.4410
- Review Panel
- CV
- Submission Type