Atlas FDA

WELTER SNARE RETRIEVER

FDA 510(k) clearance K920823 · decided 1993-03-04

Clearance details

K-number
K920823
Device name
WELTER SNARE RETRIEVER
Applicant
Cook, Inc.
Decision
Substantially Equivalent
Date received
1992-02-24
Decision date
1993-03-04
Days to decision
374 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
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

RecordFirmDate
Zenith® Iliac Branch (P020018/S064)Cook, Inc.2025-05-30
ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065)Cook, Inc.2025-04-09
Zenith Fenestrated AAA Endovascular Graft (P020018/S063)Cook, Inc.2024-04-29
Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061)Cook, Inc.2023-12-14
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
Zenith AAA Endovascular Graft (P020018/S059)Cook, Inc.2020-10-08
ZENITH FLEX AAA ENDOVASCULAR GRAFT (P020018/S055)Cook, Inc.2018-10-10