FDA 510(k)

SpyGlass Discover Balloon Dilation Catheter

K-Number: K212582 · 2022-05-06

Decision Date2022-05-06

Product CodeGCA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SpyGlass Discover Balloon Dilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212582. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpyGlass Discover Balloon Dilation Catheter?

SpyGlass Discover Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Boston Scientific Corporation. The 510(k) number is K212582.

When did SpyGlass Discover Balloon Dilation Catheter receive FDA 510(k) clearance?

SpyGlass Discover Balloon Dilation Catheter received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212582.

Who is the listed applicant for SpyGlass Discover Balloon Dilation Catheter?

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

What is the FDA product code for SpyGlass Discover Balloon Dilation Catheter?

The FDA product code for SpyGlass Discover Balloon Dilation Catheter is GCA.

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Related Devices (Code: GCA)

K253013Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd.K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)Jiangsu Vedkang Medical Science and Technology Co., Ltd.K210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd.K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc.K193344Tri-Ex Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc.

Official Source

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