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FDA 510(k)

STENT GRAFT BALLOON CATHETER

K-Number: K091624 · 2009-10-15

ApplicantVia Biomedical, Inc.
Decision Date2009-10-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STENT GRAFT BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Via Biomedical, Inc.. It received FDA 510(k) clearance on 2009-10-15 under 510(k) number K091624. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STENT GRAFT BALLOON CATHETER?

STENT GRAFT BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2009-10-15. The listed applicant is Via Biomedical, Inc.. The 510(k) number is K091624.

When did STENT GRAFT BALLOON CATHETER receive FDA 510(k) clearance?

STENT GRAFT BALLOON CATHETER received FDA 510(k) clearance on 2009-10-15, under 510(k) number K091624.

Who is the listed applicant for STENT GRAFT BALLOON CATHETER?

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

What is the FDA product code for STENT GRAFT BALLOON CATHETER?

The FDA product code for STENT GRAFT BALLOON CATHETER is DQY.

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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.

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