FDA 510(k)

DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS

K-Number: K892926 · 1989-12-05

Decision Date1989-12-05

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS is the device name listed in this FDA 510(k) record. The listed applicant is Vas-Cath, Inc.. It received FDA 510(k) clearance on 1989-12-05 under 510(k) number K892926. 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 DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS?

DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS is a medical device that received FDA 510(k) clearance on 1989-12-05. The listed applicant is Vas-Cath, Inc.. The 510(k) number is K892926.

When did DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS receive FDA 510(k) clearance?

DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS received FDA 510(k) clearance on 1989-12-05, under 510(k) number K892926.

Who is the listed applicant for DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS?

The FDA 510(k) record lists Vas-Cath, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS?

The FDA product code for DUAL LUMEN CATHETER FOR CHRONIC VASCULAR ACCESS 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 Vas-Cath, Inc. as applicant

K973013OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER K965178NIAGARA DUAL LUMEN CATHETER K964881ULTRAVERSE PTA CATHETER K970725OPTI-PLAST XL 5.5 F PTA CATHETER K941706OPTI-PLAST ANGIOPLASTY CATHETER K925485VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER

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Related Devices (Code: LJS)

K260929Neonav ECG Tip Location SystemNavi Medical Technologies K252373BioFlo 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 Vascular K252792PM2™ 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

View on FDA Database →

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