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FDA 510(k)

EPTFE VASCULAR PROSTHESIS; SEALPTFE

K-Number: K030999 · 2003-04-09

ApplicantVascutek, Ltd.
Decision Date2003-04-09
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EPTFE VASCULAR PROSTHESIS; SEALPTFE is the device name listed in this FDA 510(k) record. The listed applicant is Vascutek, Ltd.. It received FDA 510(k) clearance on 2003-04-09 under 510(k) number K030999. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPTFE VASCULAR PROSTHESIS; SEALPTFE?

EPTFE VASCULAR PROSTHESIS; SEALPTFE is a medical device that received FDA 510(k) clearance on 2003-04-09. The listed applicant is Vascutek, Ltd.. The 510(k) number is K030999.

When did EPTFE VASCULAR PROSTHESIS; SEALPTFE receive FDA 510(k) clearance?

EPTFE VASCULAR PROSTHESIS; SEALPTFE received FDA 510(k) clearance on 2003-04-09, under 510(k) number K030999.

Who is the listed applicant for EPTFE VASCULAR PROSTHESIS; SEALPTFE?

The FDA 510(k) record lists Vascutek, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPTFE VASCULAR PROSTHESIS; SEALPTFE?

The FDA product code for EPTFE VASCULAR PROSTHESIS; SEALPTFE is DSY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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