FDA 510(k)

ISIGHT IMAGING CATHETER, MODEL 38986

K-Number: K060175 · 2006-03-24

Decision Date2006-03-24

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ISIGHT IMAGING CATHETER, MODEL 38986 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 2006-03-24 under 510(k) number K060175. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISIGHT IMAGING CATHETER, MODEL 38986?

ISIGHT IMAGING CATHETER, MODEL 38986 is a medical device that received FDA 510(k) clearance on 2006-03-24. The listed applicant is Boston Scientific Corp. The 510(k) number is K060175.

When did ISIGHT IMAGING CATHETER, MODEL 38986 receive FDA 510(k) clearance?

ISIGHT IMAGING CATHETER, MODEL 38986 received FDA 510(k) clearance on 2006-03-24, under 510(k) number K060175.

Who is the listed applicant for ISIGHT IMAGING CATHETER, MODEL 38986?

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 ISIGHT IMAGING CATHETER, MODEL 38986?

The FDA product code for ISIGHT IMAGING CATHETER, MODEL 38986 is DQO.

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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.