FDA 510(k)

IVAS 10MM AND 15MM BALLOON CATHETER

K-Number: K130430 · 2013-05-23

Decision Date2013-05-23

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

IVAS 10MM AND 15MM 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 2013-05-23 under 510(k) number K130430. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVAS 10MM AND 15MM BALLOON CATHETER?

IVAS 10MM AND 15MM BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2013-05-23. The listed applicant is Stryker Corporation. The 510(k) number is K130430.

When did IVAS 10MM AND 15MM BALLOON CATHETER receive FDA 510(k) clearance?

IVAS 10MM AND 15MM BALLOON CATHETER received FDA 510(k) clearance on 2013-05-23, under 510(k) number K130430.

Who is the listed applicant for IVAS 10MM AND 15MM 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 10MM AND 15MM BALLOON CATHETER?

The FDA product code for IVAS 10MM AND 15MM BALLOON CATHETER is HRX.

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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.