510(k) K883439
K883439 is an FDA 510(k) premarket notification submitted by Medtronic Blood Systems, Inc. for the device "INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code DTR (Heat-Exchanger, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4240. Medtronic Blood Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1988
- Date Received
- August 15, 1988
- 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