Atlas FDA

TEMPORARY LIMB SALVAGE SHUNT

FDA 510(k) clearance K070323 · decided 2007-02-15

Clearance details

K-number
K070323
Device name
TEMPORARY LIMB SALVAGE SHUNT
Applicant
Vascutek, Ltd.
Decision
Substantially Equivalent
Date received
2007-02-02
Decision date
2007-02-15
Days to decision
13 days
Clearance type
Traditional
Product code
DXC
Device class
2
Regulation number
870.4450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Renfrewshire, Glasgow, GB
Third-party review
No
Expedited review
Yes

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Thoraflex™ Hybrid (P210006/S015)Vascutek, Ltd.2025-10-29
Thoraflex™ Hybrid (P210006/S014)Vascutek, Ltd.2025-10-16
Thoraflex™ Hybrid (P210006/S013)Vascutek, Ltd.2025-07-30
Thoraflex Hybrid (P210006/S012)Vascutek, Ltd.2025-04-09
Thoraflex™ Hybrid (P210006/S010)Vascutek, Ltd.2025-03-28
Thoraflex™ Hybrid (P210006/S011)Vascutek, Ltd.2025-01-27
Thoraflex™ Hybrid (P210006/S009)Vascutek, Ltd.2024-08-01
Thoraflex™ Hybrid (P210006/S007)Vascutek, Ltd.2024-01-11