FDA 510(k)

MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942

K-Number: K063312 · 2006-11-30

Decision Date2006-11-30

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 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 2006-11-30 under 510(k) number K063312. 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 MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942?

MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 is a medical device that received FDA 510(k) clearance on 2006-11-30. The listed applicant is Boston Scientific Corp. The 510(k) number is K063312.

When did MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 receive FDA 510(k) clearance?

MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 received FDA 510(k) clearance on 2006-11-30, under 510(k) number K063312.

Who is the listed applicant for MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942?

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 ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942?

The FDA product code for MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 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.