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FDA 510(k)

ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING

K-Number: K913636 · 1991-12-12

ApplicantCordis Corp.
Decision Date1991-12-12
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ORBIS-SIGMA VALVE 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 1991-12-12 under 510(k) number K913636. 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 ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING?

ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING is a medical device that received FDA 510(k) clearance on 1991-12-12. The listed applicant is Cordis Corp.. The 510(k) number is K913636.

When did ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING receive FDA 510(k) clearance?

ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING received FDA 510(k) clearance on 1991-12-12, under 510(k) number K913636.

Who is the listed applicant for ORBIS-SIGMA VALVE 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 ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING?

The FDA product code for ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING is JXG.

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Other records listing Cordis Corp. as applicant

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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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