FDA 510(k)

DAYPAK SYSTEM III CATHETER CARE KIT

K-Number: K840681 · 1984-04-16

Decision Date1984-04-16

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

DAYPAK SYSTEM III CATHETER CARE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Creative Care Systems, Inc.. It received FDA 510(k) clearance on 1984-04-16 under 510(k) number K840681. 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 DAYPAK SYSTEM III CATHETER CARE KIT?

DAYPAK SYSTEM III CATHETER CARE KIT is a medical device that received FDA 510(k) clearance on 1984-04-16. The listed applicant is Creative Care Systems, Inc.. The 510(k) number is K840681.

When did DAYPAK SYSTEM III CATHETER CARE KIT receive FDA 510(k) clearance?

DAYPAK SYSTEM III CATHETER CARE KIT received FDA 510(k) clearance on 1984-04-16, under 510(k) number K840681.

Who is the listed applicant for DAYPAK SYSTEM III CATHETER CARE KIT?

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

What is the FDA product code for DAYPAK SYSTEM III CATHETER CARE KIT?

The FDA product code for DAYPAK SYSTEM III CATHETER CARE KIT is LJS.

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Other records listing Creative Care Systems, Inc. as applicant

K861406NON-KOR WINGED INFUSION SETS K852831NON-KOR ACCESS KITS K850888PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV K850887DRESSING CHANGE KIT K841742NON-CORING NEEDLE K840919DAYPAK SYS VII CATHETER CARE KIT

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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

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