FDA 510(k)

CATHETER, INTRAVASCULAR OR PERCUTANEOUS

K-Number: K951078 · 1995-07-31

Decision Date1995-07-31

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CATHETER, INTRAVASCULAR OR PERCUTANEOUS is the device name listed in this FDA 510(k) record. The listed applicant is Sims Deltec, Inc.. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K951078. 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 CATHETER, INTRAVASCULAR OR PERCUTANEOUS?

CATHETER, INTRAVASCULAR OR PERCUTANEOUS is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Sims Deltec, Inc.. The 510(k) number is K951078.

When did CATHETER, INTRAVASCULAR OR PERCUTANEOUS receive FDA 510(k) clearance?

CATHETER, INTRAVASCULAR OR PERCUTANEOUS received FDA 510(k) clearance on 1995-07-31, under 510(k) number K951078.

Who is the listed applicant for CATHETER, INTRAVASCULAR OR PERCUTANEOUS?

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

What is the FDA product code for CATHETER, INTRAVASCULAR OR PERCUTANEOUS?

The FDA product code for CATHETER, INTRAVASCULAR OR PERCUTANEOUS is LJS.

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Other records listing Sims Deltec, Inc. as applicant

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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.