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FDA 510(k)

TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER

K-Number: K050599 · 2005-06-03

ApplicantBoston Scientific Corp
Decision Date2005-06-03
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2005-06-03 under 510(k) number K050599. 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 TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER?

TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER is a medical device that received FDA 510(k) clearance on 2005-06-03. The listed applicant is Boston Scientific Corp. The 510(k) number is K050599.

When did TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER receive FDA 510(k) clearance?

TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER received FDA 510(k) clearance on 2005-06-03, under 510(k) number K050599.

Who is the listed applicant for TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER?

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

What is the FDA product code for TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER?

The FDA product code for TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER is 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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