K-number	K241070
Device name	Gelsoft Plus Vascular Prostheses
Applicant	Vascutek, Ltd.
Product code	DSY
Device class	Class II
Decision date	Nov 15, 2024
Decision	Substantially Equivalent
Regulation	870.3450

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Source

View the full FDA submission: accessdata.fda.gov

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Gelsoft Plus Vascular Prostheses

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Gelsoft Plus Vascular Prostheses