510(k) K912604
K912604 is an FDA 510(k) premarket notification submitted by Aries Medical, Inc. for the device "SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF". The FDA issued a decision of Substantially Equivalent on October 28, 1991. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Aries Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 28, 1991
- Date Received
- May 31, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4360
- Review Panel
- CV
- Submission Type