FDA 510(k)

ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

K-Number: K050577 · 2005-03-30

Decision Date2005-03-30

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 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 2005-03-30 under 510(k) number K050577. 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 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014?

ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 is a medical device that received FDA 510(k) clearance on 2005-03-30. The listed applicant is Boston Scientific Corp. The 510(k) number is K050577.

When did ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 receive FDA 510(k) clearance?

ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 received FDA 510(k) clearance on 2005-03-30, under 510(k) number K050577.

Who is the listed applicant for ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014?

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 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014?

The FDA product code for ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 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.