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FDA 510(k)

NORCATH VASCULAR ACCESS CATHETERS

K-Number: K911067 · 1991-06-03

ApplicantNorfolk Medical
Decision Date1991-06-03
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NORCATH VASCULAR ACCESS CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Norfolk Medical. It received FDA 510(k) clearance on 1991-06-03 under 510(k) number K911067. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NORCATH VASCULAR ACCESS CATHETERS?

NORCATH VASCULAR ACCESS CATHETERS is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Norfolk Medical. The 510(k) number is K911067.

When did NORCATH VASCULAR ACCESS CATHETERS receive FDA 510(k) clearance?

NORCATH VASCULAR ACCESS CATHETERS received FDA 510(k) clearance on 1991-06-03, under 510(k) number K911067.

Who is the listed applicant for NORCATH VASCULAR ACCESS CATHETERS?

The FDA 510(k) record lists Norfolk Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORCATH VASCULAR ACCESS CATHETERS?

The FDA product code for NORCATH VASCULAR ACCESS CATHETERS is LJS.

Related Clinical Trials

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.

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Other records listing Norfolk Medical 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.

K111101NORPORT CT-PC, LUCENT NON-CORING NEEDEL INFUSION SETK905646OMEGAPORT SUBCUTANEOUSLY IMPLANTED DRUG DELIVERY

Related Devices (Code: LJS)

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.

K260929Neonav ECG Tip Location SystemNavi Medical TechnologiesK252373BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve TechnologySpectrum VascularK252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.K243458HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); HydrAccess Vascular, Inc.K251212Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)Access Vascular, Inc.K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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