FDA 510(k)

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip

K-Number: K153500 · 2016-01-27

Decision Date2016-01-27

Product CodeFZP

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip is the device name listed in this FDA 510(k) record. The listed applicant is AtriCure, Inc.. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K153500. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is AtriCure, Inc.. The 510(k) number is K153500.

When did AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip receive FDA 510(k) clearance?

AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip received FDA 510(k) clearance on 2016-01-27, under 510(k) number K153500.

Who is the listed applicant for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip?

The FDA 510(k) record lists AtriCure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip?

The FDA product code for AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip is FZP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.