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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 the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 2019-12-26 under 510(k) 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. The listed applicant is Datascope Corp.. The 510(k) number is K190884.

When did TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool receive FDA 510(k) clearance?

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

Who is the listed applicant for TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool?

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

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.

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Related Devices (Code: GDW)

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Official Source

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