FDA 510(k)

TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815

K-Number: K022357 · 2002-10-16

Decision Date2002-10-16

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific, Target. It received FDA 510(k) clearance on 2002-10-16 under 510(k) number K022357. 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 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815?

TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 is a medical device that received FDA 510(k) clearance on 2002-10-16. The listed applicant is Boston Scientific, Target. The 510(k) number is K022357.

When did TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 receive FDA 510(k) clearance?

TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 received FDA 510(k) clearance on 2002-10-16, under 510(k) number K022357.

Who is the listed applicant for TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815?

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

What is the FDA product code for TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815?

The FDA product code for TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 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.