FDA 510(k)

IMAGER II ANGIOGRAPHIC CATHETERS

K-Number: K120893 · 2012-03-29

Decision Date2012-03-29

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IMAGER II ANGIOGRAPHIC CATHETERS 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 2012-03-29 under 510(k) number K120893. 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 IMAGER II ANGIOGRAPHIC CATHETERS?

IMAGER II ANGIOGRAPHIC CATHETERS is a medical device that received FDA 510(k) clearance on 2012-03-29. The listed applicant is Boston Scientific Corp. The 510(k) number is K120893.

When did IMAGER II ANGIOGRAPHIC CATHETERS receive FDA 510(k) clearance?

IMAGER II ANGIOGRAPHIC CATHETERS received FDA 510(k) clearance on 2012-03-29, under 510(k) number K120893.

Who is the listed applicant for IMAGER II ANGIOGRAPHIC CATHETERS?

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 IMAGER II ANGIOGRAPHIC CATHETERS?

The FDA product code for IMAGER II ANGIOGRAPHIC CATHETERS 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.