FDA 510(k)

MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX

K-Number: K052783 · 2005-10-27

Decision Date2005-10-27

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX 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 2005-10-27 under 510(k) number K052783. 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 MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX?

MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX is a medical device that received FDA 510(k) clearance on 2005-10-27. The listed applicant is Boston Scientific Corp. The 510(k) number is K052783.

When did MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX receive FDA 510(k) clearance?

MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX received FDA 510(k) clearance on 2005-10-27, under 510(k) number K052783.

Who is the listed applicant for MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX?

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 MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX?

The FDA product code for MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX 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.