Atlas FDA

GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET

FDA 510(k) clearance K032426 · decided 2003-10-31

Clearance details

K-number
K032426
Device name
GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET
Applicant
Cook, Inc.
Decision
Substantially Equivalent
Date received
2003-08-06
Decision date
2003-10-31
Days to decision
86 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Bloomington, IN, 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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ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055)Cook, Inc.2018-10-10