Atlas FDA

GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION

FDA 510(k) clearance K851243 · decided 1986-03-14

Clearance details

K-number
K851243
Device name
GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION
Applicant
Cook, Inc.
Decision
Substantially Equivalent
Date received
1985-02-26
Decision date
1986-03-14
Days to decision
381 days
Clearance type
Traditional
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
New Brunswick, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062)Cook, Inc.2023-12-13
Zenith Fenestrated AAA Endovascular Graft (P020018/S060)Cook, Inc.2022-01-20
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