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FDA 510(k)

PS MEDICAL VENTRICULOSTOMY KIT

K-Number: K915546 · 1991-12-30

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1991-12-30
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PS MEDICAL VENTRICULOSTOMY KIT 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 1991-12-30 under 510(k) number K915546. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PS MEDICAL VENTRICULOSTOMY KIT?

PS MEDICAL VENTRICULOSTOMY KIT is a medical device that received FDA 510(k) clearance on 1991-12-30. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K915546.

When did PS MEDICAL VENTRICULOSTOMY KIT receive FDA 510(k) clearance?

PS MEDICAL VENTRICULOSTOMY KIT received FDA 510(k) clearance on 1991-12-30, under 510(k) number K915546.

Who is the listed applicant for PS MEDICAL VENTRICULOSTOMY KIT?

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 PS MEDICAL VENTRICULOSTOMY KIT?

The FDA product code for PS MEDICAL VENTRICULOSTOMY KIT is HBG.

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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 KITK934796IPI LOW PROFILE IMPORTK934167IPI DUAL LUMEN PORTK940096PS MEDICAL CATHETER PLACEMENT KIT

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Related Devices (Code: HBG)

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.

K252696LEGACYPhasor Health, LLCK153587Taps for Resorbable ScrewsSynthes (USA) Products, LLCK162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.K122456MRII CRAINIAL DRILLMri Interventions, Inc.K022712HAND DRILL, MODEL 11-9901-7Medical Design, LLC

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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