Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip

K-Number: K163261 · 2017-05-19

ApplicantAtriCure, Inc.
Decision Date2017-05-19
Product CodeFZP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip is a medical device manufactured by AtriCure, Inc.. It received FDA 510(k) clearance on 2017-05-19 under approval number K163261. 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 PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip?

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip is a medical device that received FDA 510(k) clearance on 2017-05-19. It is manufactured by AtriCure, Inc.. The 510(k) number is K163261.

When was AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip approved by the FDA?

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip received FDA 510(k) clearance on 2017-05-19, under approval number K163261.

What company makes AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip?

AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip is manufactured by AtriCure, Inc..

What is the FDA product code for AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip?

The FDA product code for AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip is FZP.

Related Clinical Trials

NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06099015 Cera™ Vascular Plug System Post-Market Clinical Follow-Up RECRUITING NCT07232030 Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure ENROLLING_BY_INVITATION NCT07601503 Evaluating In-line Chlorination in Nigeria NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

Other Devices by AtriCure, Inc.

K152337cryoFORM cryoICE cryoablation probe K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip K173031AtriClip LAA Exclusion System with Preloaded PRO·V Clip K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2) K163408Isolator Multifunctional Linear Pen

View all 34 devices →

Related Devices (Code: FZP)

K161758Weck Auto Endo10 Automatic Endoscopic Clip ApplierTeleflex Medical K151943Vas-Q-ClipNanova Biomaterials, Inc. K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc. K152082Vesocclude Polymer Ligating ClipVesocclude Medical, LLC K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc. K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.

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.

↑