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FDA 510(k)

H-H SHUNT INTRODUCER

K-Number: K853368 · 1985-09-06

ApplicantHolter-Hausner Intl.
Decision Date1985-09-06
Product CodeGYK
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

H-H SHUNT INTRODUCER 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 1985-09-06 under 510(k) number K853368. The device is classified under product code GYK. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the H-H SHUNT INTRODUCER?

H-H SHUNT INTRODUCER is a medical device that received FDA 510(k) clearance on 1985-09-06. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K853368.

When did H-H SHUNT INTRODUCER receive FDA 510(k) clearance?

H-H SHUNT INTRODUCER received FDA 510(k) clearance on 1985-09-06, under 510(k) number K853368.

Who is the listed applicant for H-H SHUNT INTRODUCER?

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 SHUNT INTRODUCER?

The FDA product code for H-H SHUNT INTRODUCER is GYK.

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Other records listing Holter-Hausner Intl. as applicant

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K875287H-H FLUSHING RESERVOIRK874508H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAGK872293H-H HUNTER ACTIVE TENDON IMPLANT BCK872285H-H HUNTER ACTIVE TENDON IMPLANT DCK872284H-H HUNTER ACTIVE TENDON IMPLANT PCK871351H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP

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Related Devices (Code: GYK)

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.

K962761REIGEL TUNNELING DEVICECook, Inc.K934391V/P AND L/P CATHETER PASSERSRadionics, Inc.K930606PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSERPudenz-Schulte Medical Research Corp.K932273CORDIS TUNNELERCordis Corp.K895868HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSEBaxter Healthcare CorpK883607PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETERCodman & Shurtleff, 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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