FDA 510(k)

BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)

K-Number: K954582 · 1995-12-07

Decision Date1995-12-07

Product CodeDSY

Advisory CommitteeCV

DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 1995-12-07 under 510(k) number K954582. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)?

BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-12-07. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K954582.

When did BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) receive FDA 510(k) clearance?

BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) received FDA 510(k) clearance on 1995-12-07, under 510(k) number K954582.

Who is the listed applicant for BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)?

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

What is the FDA product code for BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)?

The FDA product code for BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) is DSY.

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Official Source

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