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FDA 510(k)

CATHLAB SILICONE BILIARY BALLOON CATHETER

K-Number: K910917 · 1991-08-02

ApplicantCathlab Corp.
Decision Date1991-08-02
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHLAB SILICONE BILIARY BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cathlab Corp.. It received FDA 510(k) clearance on 1991-08-02 under 510(k) number K910917. 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 CATHLAB SILICONE BILIARY BALLOON CATHETER?

CATHLAB SILICONE BILIARY BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is Cathlab Corp.. The 510(k) number is K910917.

When did CATHLAB SILICONE BILIARY BALLOON CATHETER receive FDA 510(k) clearance?

CATHLAB SILICONE BILIARY BALLOON CATHETER received FDA 510(k) clearance on 1991-08-02, under 510(k) number K910917.

Who is the listed applicant for CATHLAB SILICONE BILIARY BALLOON CATHETER?

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

What is the FDA product code for CATHLAB SILICONE BILIARY BALLOON CATHETER?

The FDA product code for CATHLAB SILICONE BILIARY BALLOON CATHETER is GCA.

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Other records listing Cathlab Corp. as applicant

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.

K910916CATHLAB SILICONE OCCLUSION BALLOON CATHETERK905139CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETERK897051MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATHK8971843F AND 4F IRRIGATION EMBOLECTOMY CATHETERSK893435SILICONE FLOW-DIRECTED THERMODILUTION CATHETERK893680SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

View all 8 devices →

Related Devices (Code: GCA)

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.

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.K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific CorporationK210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd.K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, 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.

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