FDA 510(k)

RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612

K-Number: K122660 · 2012-12-03

Decision Date2012-12-03

Product CodePKL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2012-12-03 under 510(k) number K122660. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612?

RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 is a medical device that received FDA 510(k) clearance on 2012-12-03. The listed applicant is Boston Scientific Corporation. The 510(k) number is K122660.

When did RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 receive FDA 510(k) clearance?

RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 received FDA 510(k) clearance on 2012-12-03, under 510(k) number K122660.

Who is the listed applicant for RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612?

The FDA product code for RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 is PKL.

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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.