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FDA 510(k)

HH SUBCUTANEOUS ACCESS PORT

K-Number: K833672 · 1984-03-06

ApplicantHolter-Hausner Intl.
Decision Date1984-03-06
Product CodeLKG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HH SUBCUTANEOUS ACCESS PORT 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 1984-03-06 under 510(k) number K833672. The device is classified under product code LKG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HH SUBCUTANEOUS ACCESS PORT?

HH SUBCUTANEOUS ACCESS PORT is a medical device that received FDA 510(k) clearance on 1984-03-06. The listed applicant is Holter-Hausner Intl.. The 510(k) number is K833672.

When did HH SUBCUTANEOUS ACCESS PORT receive FDA 510(k) clearance?

HH SUBCUTANEOUS ACCESS PORT received FDA 510(k) clearance on 1984-03-06, under 510(k) number K833672.

Who is the listed applicant for HH SUBCUTANEOUS ACCESS PORT?

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 HH SUBCUTANEOUS ACCESS PORT?

The FDA product code for HH SUBCUTANEOUS ACCESS PORT is LKG.

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Other records listing Holter-Hausner Intl. as applicant

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Related Devices (Code: LKG)

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.

K950315CORDIS CSF RESERVOIRCordis Corp.K881690PORT-A-CATH PORTAL INTRODUCER FORCEPSPharmacia Deltec, Inc.K881493PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.Pharmacia Deltec, Inc.K874498CSF-VENTRICULOSTOMY RESERVOIRPudenz-Schulte Medical Research Corp.K874468P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.K833822P-S MEDICAL CSF ACCESS DEV 15MM/25MMPudenz-Schulte Medical Research Corp.

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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