Atlas FDA

CUSTOMED ANGIODRAPE PACK FEMORAL

FDA 510(k) clearance K904694 · decided 1991-01-02

Clearance details

K-number
K904694
Device name
CUSTOMED ANGIODRAPE PACK FEMORAL
Applicant
Customed, Inc.
Decision
Unknown
Date received
1990-10-16
Decision date
1991-01-02
Days to decision
78 days
Clearance type
Traditional
Product code
KKX
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Carolina Puerto Rico, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical pro recall (Z-1431-2016)Customed, Inc2016-04-14
Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical pr recall (Z-1442-2016)Customed, Inc2016-04-14
ANGIODRAPE PK 4/CS Used by medical staff to perform surgical procedures and patient care p recall (Z-2548-2015)Customed, Inc2015-09-03
ANGIOGRAPHY PK 5/CS Used by medical staff to perform surgical procedures and patient care recall (Z-2588-2015)Customed, Inc2015-09-03
FEMORAL PACK 5/CS Used by medical staff to perform surgical procedures and patient care pr recall (Z-2598-2015)Customed, Inc2015-09-03
ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and pa recall (Z-2622-2015)Customed, Inc2015-09-03
KNEE ARTHROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient recall (Z-2623-2015)Customed, Inc2015-09-03
FEMORAL PACK 4/CS Used by medical staff to perform surgical procedures and patient care pr recall (Z-2624-2015)Customed, Inc2015-09-03
ANGIODRAPE PACK DAMAS 6/CS Used by medical staff to perform surgical procedures and patien recall (Z-2671-2015)Customed, Inc2015-09-03
ANGIOGRAPHY PACK 5/CS Used by medical staff to perform surgical procedures and patient car recall (Z-2691-2015)Customed, Inc2015-09-03
GENERAL MINOR PK 5/CS Used by medical staff to perform surgical procedures and patient car recall (Z-2704-2015)Customed, Inc2015-09-03