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FDA 510(k)

PERITONEAL/CARDIAC CATHETER

K-Number: K970983 · 1997-06-13

ApplicantIntegra Neurocare, LLC
Decision Date1997-06-13
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PERITONEAL/CARDIAC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Integra Neurocare, LLC. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K970983. 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 PERITONEAL/CARDIAC CATHETER?

PERITONEAL/CARDIAC CATHETER is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Integra Neurocare, LLC. The 510(k) number is K970983.

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

PERITONEAL/CARDIAC CATHETER received FDA 510(k) clearance on 1997-06-13, under 510(k) number K970983.

Who is the listed applicant for PERITONEAL/CARDIAC CATHETER?

The FDA 510(k) record lists Integra Neurocare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERITONEAL/CARDIAC CATHETER?

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

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Other records listing Integra Neurocare, LLC 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.

K002392VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-VK992006NEUROVIEW INSTRUMENT HOLDER, MODEL 300-33K981246BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)K973525MAURICE WORLDWIDE SHUNT SYSTEMK972994EXTERNAL CSF DRAINAGE MANAGEMENT SYSTEMSK972261RIVETTI-LEVINSON INSTRALUMINAL SHUNT

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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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