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FDA 510(k)

VASCULAR ACCESS CATHETER ACCESSORIES

K-Number: K935380 · 1995-02-17

ApplicantBard Access Systems, Inc.
Decision Date1995-02-17
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

VASCULAR ACCESS CATHETER ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 1995-02-17 under 510(k) number K935380. 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 VASCULAR ACCESS CATHETER ACCESSORIES?

VASCULAR ACCESS CATHETER ACCESSORIES is a medical device that received FDA 510(k) clearance on 1995-02-17. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K935380.

When did VASCULAR ACCESS CATHETER ACCESSORIES receive FDA 510(k) clearance?

VASCULAR ACCESS CATHETER ACCESSORIES received FDA 510(k) clearance on 1995-02-17, under 510(k) number K935380.

Who is the listed applicant for VASCULAR ACCESS CATHETER ACCESSORIES?

The FDA 510(k) record lists Bard Access Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VASCULAR ACCESS CATHETER ACCESSORIES?

The FDA product code for VASCULAR ACCESS CATHETER ACCESSORIES is LJS.

Related Clinical Trials

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Other records listing Bard Access Systems, Inc. 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.

K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port; PowerPort™ duo M.R.I. ™ Implantable PortK251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port; PowerPort™ M.R.I.™ isp Implantable PortK241353PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle SetK242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsK240146BD Prevue™ II Peripheral Vascular Access SystemK222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly

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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

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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