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FDA 510(k)

XTRAK SUPPORT CATHETER

K-Number: K032660 · 2003-10-29

ApplicantXtrak Medical, Inc.
Decision Date2003-10-29
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

XTRAK SUPPORT CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Xtrak Medical, Inc.. It received FDA 510(k) clearance on 2003-10-29 under 510(k) number K032660. 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 XTRAK SUPPORT CATHETER?

XTRAK SUPPORT CATHETER is a medical device that received FDA 510(k) clearance on 2003-10-29. The listed applicant is Xtrak Medical, Inc.. The 510(k) number is K032660.

When did XTRAK SUPPORT CATHETER receive FDA 510(k) clearance?

XTRAK SUPPORT CATHETER received FDA 510(k) clearance on 2003-10-29, under 510(k) number K032660.

Who is the listed applicant for XTRAK SUPPORT CATHETER?

The FDA 510(k) record lists Xtrak Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTRAK SUPPORT CATHETER?

The FDA product code for XTRAK SUPPORT CATHETER is DQY.

Related Clinical Trials

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Other records listing Xtrak Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021641XTD THROMBECTOMY CATHETER, XX CMK013473XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL

Related Devices (Code: DQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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