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FDA 510(k)

VASCUTEK VASCULAR PROTHESIS VP1200K/50K

K-Number: K830016 · 1983-12-21

ApplicantPacesetter Systems
Decision Date1983-12-21
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASCUTEK VASCULAR PROTHESIS VP1200K/50K is the device name listed in this FDA 510(k) record. The listed applicant is Pacesetter Systems. It received FDA 510(k) clearance on 1983-12-21 under 510(k) number K830016. 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 VASCUTEK VASCULAR PROTHESIS VP1200K/50K?

VASCUTEK VASCULAR PROTHESIS VP1200K/50K is a medical device that received FDA 510(k) clearance on 1983-12-21. The listed applicant is Pacesetter Systems. The 510(k) number is K830016.

When did VASCUTEK VASCULAR PROTHESIS VP1200K/50K receive FDA 510(k) clearance?

VASCUTEK VASCULAR PROTHESIS VP1200K/50K received FDA 510(k) clearance on 1983-12-21, under 510(k) number K830016.

Who is the listed applicant for VASCUTEK VASCULAR PROTHESIS VP1200K/50K?

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

What is the FDA product code for VASCUTEK VASCULAR PROTHESIS VP1200K/50K?

The FDA product code for VASCUTEK VASCULAR PROTHESIS VP1200K/50K is DSY.

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Other records listing Pacesetter Systems as applicant

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Related Devices (Code: DSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

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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