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FDA 510(k)

OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING

K-Number: K903844 · 1990-12-28

ApplicantCordis Corp.
Decision Date1990-12-28
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1990-12-28 under 510(k) number K903844. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING?

OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING is a medical device that received FDA 510(k) clearance on 1990-12-28. The listed applicant is Cordis Corp.. The 510(k) number is K903844.

When did OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING receive FDA 510(k) clearance?

OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING received FDA 510(k) clearance on 1990-12-28, under 510(k) number K903844.

Who is the listed applicant for OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING?

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

What is the FDA product code for OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING?

The FDA product code for OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING is JXG.

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Other records listing Cordis Corp. as applicant

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K112797POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETERK101651ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIREK082143MICRO GUIDE CATHETER XPK062798SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MBK060877PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAXK050645CORDIS AMIIA .014 PTA BALLOON CATHETER

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Related Devices (Code: JXG)

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.

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production CorporationK251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)SophysaK252514EVAC-MRIPhasor Health, LLCK243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production CorporationK243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

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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