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FDA 510(k)

CSF-CARDIAC/PERITONEAL CATHETER

K-Number: K792005 · 1980-01-16

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1980-01-16
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CSF-CARDIAC/PERITONEAL CATHETER 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 1980-01-16 under 510(k) number K792005. 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 CSF-CARDIAC/PERITONEAL CATHETER?

CSF-CARDIAC/PERITONEAL CATHETER is a medical device that received FDA 510(k) clearance on 1980-01-16. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K792005.

When did CSF-CARDIAC/PERITONEAL CATHETER receive FDA 510(k) clearance?

CSF-CARDIAC/PERITONEAL CATHETER received FDA 510(k) clearance on 1980-01-16, under 510(k) number K792005.

Who is the listed applicant for CSF-CARDIAC/PERITONEAL CATHETER?

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-CARDIAC/PERITONEAL CATHETER?

The FDA product code for CSF-CARDIAC/PERITONEAL CATHETER is JXG.

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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: 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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