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FDA 510(k)

IVAS 2-10MM (10 GUAGE) BALLON CATHETER

K-Number: K103807 · 2011-06-28

ApplicantStryker Corporation
Decision Date2011-06-28
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IVAS 2-10MM (10 GUAGE) BALLON 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 2011-06-28 under 510(k) number K103807. 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 2-10MM (10 GUAGE) BALLON CATHETER?

IVAS 2-10MM (10 GUAGE) BALLON CATHETER is a medical device that received FDA 510(k) clearance on 2011-06-28. The listed applicant is Stryker Corporation. The 510(k) number is K103807.

When did IVAS 2-10MM (10 GUAGE) BALLON CATHETER receive FDA 510(k) clearance?

IVAS 2-10MM (10 GUAGE) BALLON CATHETER received FDA 510(k) clearance on 2011-06-28, under 510(k) number K103807.

Who is the listed applicant for IVAS 2-10MM (10 GUAGE) BALLON 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 2-10MM (10 GUAGE) BALLON CATHETER?

The FDA product code for IVAS 2-10MM (10 GUAGE) BALLON 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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