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FDA 510(k)

CSF-VENTRICULOSTOMY RESERVOIR

K-Number: K874498 · 1988-02-11

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1988-02-11
Product CodeLKG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CSF-VENTRICULOSTOMY RESERVOIR is the device name listed in this FDA 510(k) record. The listed applicant is Pudenz-Schulte Medical Research Corp.. It received FDA 510(k) clearance on 1988-02-11 under 510(k) number K874498. 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 CSF-VENTRICULOSTOMY RESERVOIR?

CSF-VENTRICULOSTOMY RESERVOIR is a medical device that received FDA 510(k) clearance on 1988-02-11. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K874498.

When did CSF-VENTRICULOSTOMY RESERVOIR receive FDA 510(k) clearance?

CSF-VENTRICULOSTOMY RESERVOIR received FDA 510(k) clearance on 1988-02-11, under 510(k) number K874498.

Who is the listed applicant for CSF-VENTRICULOSTOMY RESERVOIR?

The FDA 510(k) record lists Pudenz-Schulte Medical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CSF-VENTRICULOSTOMY RESERVOIR?

The FDA product code for CSF-VENTRICULOSTOMY RESERVOIR is LKG.

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Other records listing Pudenz-Schulte Medical Research Corp. as applicant

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.

K960055MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932K954409PS MEDICAL IPI VASCULAR ACCESS CATHETERK951258PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KITK934167IPI DUAL LUMEN PORTK934796IPI LOW PROFILE IMPORTK940096PS MEDICAL CATHETER PLACEMENT KIT

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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.K874468P-S MEDICAL VENTRICULAR ACCESS PORTPudenz-Schulte Medical Research Corp.K833822P-S MEDICAL CSF ACCESS DEV 15MM/25MMPudenz-Schulte Medical Research Corp.K833672HH SUBCUTANEOUS ACCESS PORTHolter-Hausner Intl.

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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