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FDA 510(k)

AtriClip LAA Exclusion System with Preloaded PRO·V Clip

K-Number: K173031 · 2017-10-25

ApplicantAtriCure, Inc.
Decision Date2017-10-25
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriClip LAA Exclusion System with Preloaded 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 2017-10-25 under 510(k) number K173031. 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 PRO·V Clip?

AtriClip LAA Exclusion System with Preloaded PRO·V Clip is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is AtriCure, Inc.. The 510(k) number is K173031.

When did AtriClip LAA Exclusion System with Preloaded PRO·V Clip receive FDA 510(k) clearance?

AtriClip LAA Exclusion System with Preloaded PRO·V Clip received FDA 510(k) clearance on 2017-10-25, under 510(k) number K173031.

Who is the listed applicant for AtriClip LAA Exclusion System with Preloaded 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 PRO·V Clip?

The FDA product code for AtriClip LAA Exclusion System with Preloaded PRO·V Clip is FZP.

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Related Devices (Code: FZP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical CorporationK253903InnoClip Disposable Clip ApplierTaiwan Surgical CorporationK253781InnoClip Clip ApplierTaiwan Surgical CorporationK250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex MedicalK242541GEM ZIPCLIPSynovis Micro Companies Alliance A Subsidiary of Baxter Int

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.

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