FDA 510(k)

NON-STERILE CATHETER REPAIR KITS

K-Number: K830406 · 1983-03-01

Decision Date1983-03-01

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NON-STERILE CATHETER REPAIR KITS is the device name listed in this FDA 510(k) record. The listed applicant is Evermed, Inc.. It received FDA 510(k) clearance on 1983-03-01 under 510(k) number K830406. 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 NON-STERILE CATHETER REPAIR KITS?

NON-STERILE CATHETER REPAIR KITS is a medical device that received FDA 510(k) clearance on 1983-03-01. The listed applicant is Evermed, Inc.. The 510(k) number is K830406.

When did NON-STERILE CATHETER REPAIR KITS receive FDA 510(k) clearance?

NON-STERILE CATHETER REPAIR KITS received FDA 510(k) clearance on 1983-03-01, under 510(k) number K830406.

Who is the listed applicant for NON-STERILE CATHETER REPAIR KITS?

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

What is the FDA product code for NON-STERILE CATHETER REPAIR KITS?

The FDA product code for NON-STERILE CATHETER REPAIR KITS is LJS.

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Other records listing Evermed, Inc. as applicant

K840846STERILE HICHMAN/BROVIAC INJECTION CAP K840529STEIGER TUNNELING INSTRUMENT 285 K830256NON-STERILE BROVIAC PARENTERAL ALIMI-K830233NON-STERILE,SINGLE/SOUBLE LUMEN-CATH K830257NON-STERILE PERITONEAL ACCESS CATHET-

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

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