Atlas FDA

NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS

FDA 510(k) clearance K934847 · decided 1994-04-15

Clearance details

K-number
K934847
Device name
NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
Applicant
Sorin Biomedical, Inc.
Decision
Substantially Equivalent
Date received
1993-10-08
Decision date
1994-04-15
Days to decision
189 days
Clearance type
Traditional
Product code
DTN
Device class
2
Regulation number
870.4400
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt recall (Z-1009-04)Cobe Cardiovascular, Inc2004-07-20
Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. recall (Z-0960-03)Cobe Cardiovascular, Inc2003-07-02