510(k) clearances

Gelweave™ Vascular Prostheses

Vascutek, Ltd. · Cardiovascular

K241550Substantially EquivalentTraditionalDSY
Open FDA's page for this record
Third party flag
N
City
Inchinnan
Advisory committee description
Cardiovascular
Address 1
Newmains Ave.
Statement or summary
Summary
Product code
DSY
Zip code
PA49RR
Applicant
Vascutek, Ltd.
Decision date
2025-02-27
Decision code
SESE
Country code
GB
Device name
Gelweave™ Vascular Prostheses
Advisory committee
CV
Contact
Ryan King
K number
K241550
Date received
2024-05-31
Review advisory committee
CV
Postal code
PA49RR
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Medical specialty description
Cardiovascular
Regulation number
870.3450
Device class
2
Registration number
2020394, 3008307705, 1724474, 1220948, 3010162973, 3015225571, 3010097171, 1723241, 1640201, 1721504, 3045042524, 1720929, 2242352, 3010407203, 3011175548, 3012536737, 3013718163, 3033589330, 2017233, 1220477, 2246552, 9612515, 3006950086, 1018233, 1721676, 3006082230, 3015309643, 3007676031
FEI number
2020394, 3008307705, 1220948, 1000517719, 3003094851, 3015225571, 3010097171, 3002807041, 1721504, 3002808437, 3045042524, 1720929, 2242352, 3010407203, 3011175548, 3012536737, 3013718163, 3033589330, 2017233, 1220477, 2246552, 3002707083, 3006950086, 1018233, 1721676, 3006082230, 3015309643, 3007676031
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.