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FDA 510(k)

VENAFLO II VASCULAR GRAFT

K-Number: K052282 · 2005-09-20

Decision Date2005-09-20
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENAFLO II VASCULAR GRAFT is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2005-09-20 under 510(k) number K052282. 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 VENAFLO II VASCULAR GRAFT?

VENAFLO II VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 2005-09-20. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K052282.

When did VENAFLO II VASCULAR GRAFT receive FDA 510(k) clearance?

VENAFLO II VASCULAR GRAFT received FDA 510(k) clearance on 2005-09-20, under 510(k) number K052282.

Who is the listed applicant for VENAFLO II VASCULAR GRAFT?

The FDA 510(k) record lists Bard Peripheral Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VENAFLO II VASCULAR GRAFT?

The FDA product code for VENAFLO II VASCULAR GRAFT is DSY.

Related Clinical Trials

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.

Other records listing Bard Peripheral Vascular, Inc. as applicant

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.

View all 33 devices →

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.

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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