FDA 510(k)

BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES

K-Number: K951307 · 1995-06-22

Decision Date1995-06-22

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1995-06-22 under 510(k) number K951307. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES?

BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES is a medical device that received FDA 510(k) clearance on 1995-06-22. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K951307.

When did BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES receive FDA 510(k) clearance?

BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES received FDA 510(k) clearance on 1995-06-22, under 510(k) number K951307.

Who is the listed applicant for BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES?

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

What is the FDA product code for BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES?

The FDA product code for BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES is DQX.

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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.