Atlas FDA

CLEAR CARDIOPLEJIA DELIVERY SYSTEM

FDA 510(k) clearance K823451 · decided 1983-01-14

Clearance details

K-number
K823451
Device name
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
Applicant
3M Health Care, Sarns
Decision
Substantially Equivalent
Date received
1982-11-17
Decision date
1983-01-14
Days to decision
58 days
Clearance type
Traditional
Product code
DTR
Device class
2
Regulation number
870.4240
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Deliv recall (Z-0158-2015)Terumo Cardiovascular Systems Corp2014-10-31
Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937 recall (Z-2149-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABL recall (Z-2151-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01 recall (Z-2152-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01 recall (Z-2153-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01 recall (Z-2154-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733 recall (Z-2155-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP recall (Z-2156-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934 recall (Z-2157-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA recall (Z-2158-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790 recall (Z-2159-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846 recall (Z-2160-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02 recall (Z-2161-2010)Terumo Cardiovascular Systems Corp2010-08-02
Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01 recall (Z-2162-2010)Terumo Cardiovascular Systems Corp2010-08-02