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FDA 510(k)

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool

K-Number: K190884 · 2019-12-26

ApplicantDatascope Corp.
Decision Date2019-12-26
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool is a medical device manufactured by Datascope Corp.. It received FDA 510(k) clearance on 2019-12-26 under approval number K190884. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool?

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool is a medical device that received FDA 510(k) clearance on 2019-12-26. It is manufactured by Datascope Corp.. The 510(k) number is K190884.

When was TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool approved by the FDA?

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool received FDA 510(k) clearance on 2019-12-26, under approval number K190884.

What company makes TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool?

TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool is manufactured by Datascope Corp..

What is the FDA product code for TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool?

The FDA product code for TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool is GDW.

Related Clinical Trials

NCT07278869 Applause Study I - Append System Early Feasibility Study RECRUITING NCT07523620 Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration RECRUITING NCT07262255 WATCHMAN FLX Pro European Registry RECRUITING NCT05147792 The CONFORM Pivotal Trial RECRUITING NCT06165510 Convergent Ablation Plus Left Atrial Appendage Isolation for the Treatment of Persistent Atrial Fibrillation RECRUITING NCT04394546 CHAMPION-AF Clinical Trial ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40712270 Comparing Claims Data to Stroke and Bleeding in the NCDR Left Atrial Appendage Occlusion Registry. JACC. Advances (2025)

Other Devices by Datascope Corp.

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Related Devices (Code: GDW)

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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.

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