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FDA 510(k)

TRANSGATE GUIDE CATHETER

K-Number: K132542 · 2013-11-15

ApplicantStryker Neurovascular
Decision Date2013-11-15
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRANSGATE GUIDE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2013-11-15 under 510(k) number K132542. 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 TRANSGATE GUIDE CATHETER?

TRANSGATE GUIDE CATHETER is a medical device that received FDA 510(k) clearance on 2013-11-15. The listed applicant is Stryker Neurovascular. The 510(k) number is K132542.

When did TRANSGATE GUIDE CATHETER receive FDA 510(k) clearance?

TRANSGATE GUIDE CATHETER received FDA 510(k) clearance on 2013-11-15, under 510(k) number K132542.

Who is the listed applicant for TRANSGATE GUIDE CATHETER?

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

What is the FDA product code for TRANSGATE GUIDE CATHETER?

The FDA product code for TRANSGATE GUIDE CATHETER is DQY.

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Related Devices (Code: DQY)

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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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