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FDA 510(k)

IVAS BALLOON CATHETER

K-Number: K113154 · 2012-01-24

ApplicantStryker Corporation
Decision Date2012-01-24
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IVAS BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2012-01-24 under 510(k) number K113154. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVAS BALLOON CATHETER?

IVAS BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2012-01-24. The listed applicant is Stryker Corporation. The 510(k) number is K113154.

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

IVAS BALLOON CATHETER received FDA 510(k) clearance on 2012-01-24, under 510(k) number K113154.

Who is the listed applicant for IVAS BALLOON CATHETER?

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

What is the FDA product code for IVAS BALLOON CATHETER?

The FDA product code for IVAS BALLOON CATHETER is NDN.

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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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