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FDA 510(k)

H-H VENTRICULAR CATHETERS & RESERVOIRS

K-Number: K853361 · 1985-08-28

ApplicantHolter-Hausner Intl.
Decision Date1985-08-28
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

H-H VENTRICULAR CATHETERS & RESERVOIRS is the device name listed in this FDA 510(k) record. The listed applicant is Holter-Hausner Intl.. It received FDA 510(k) clearance on 1985-08-28 under 510(k) number K853361. 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 H-H VENTRICULAR CATHETERS & RESERVOIRS?

H-H VENTRICULAR CATHETERS & RESERVOIRS is a medical device that received FDA 510(k) clearance on 1985-08-28. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K853361.

When did H-H VENTRICULAR CATHETERS & RESERVOIRS receive FDA 510(k) clearance?

H-H VENTRICULAR CATHETERS & RESERVOIRS received FDA 510(k) clearance on 1985-08-28, under 510(k) number K853361.

Who is the listed applicant for H-H VENTRICULAR CATHETERS & RESERVOIRS?

The FDA 510(k) record lists Holter-Hausner Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-H VENTRICULAR CATHETERS & RESERVOIRS?

The FDA product code for H-H VENTRICULAR CATHETERS & RESERVOIRS is JXG.

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Other records listing Holter-Hausner Intl. 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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