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FDA 510(k)

STRYKER IVAS BALLOON CATHETER

K-Number: K123942 · 2013-04-03

ApplicantStryker Corporation
Decision Date2013-04-03
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

STRYKER 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 2013-04-03 under 510(k) number K123942. 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 STRYKER IVAS BALLOON CATHETER?

STRYKER IVAS BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2013-04-03. The listed applicant is Stryker Corporation. The 510(k) number is K123942.

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

STRYKER IVAS BALLOON CATHETER received FDA 510(k) clearance on 2013-04-03, under 510(k) number K123942.

Who is the listed applicant for STRYKER 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 STRYKER IVAS BALLOON CATHETER?

The FDA product code for STRYKER 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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