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FDA 510(k)

ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504

K-Number: K100635 · 2010-08-27

ApplicantArrow Intl., Inc.
Decision Date2010-08-27
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 2010-08-27 under 510(k) number K100635. 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 ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504?

ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K100635.

When did ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 receive FDA 510(k) clearance?

ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 received FDA 510(k) clearance on 2010-08-27, under 510(k) number K100635.

Who is the listed applicant for ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504?

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

What is the FDA product code for ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504?

The FDA product code for ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 is LJS.

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Other records listing Arrow Intl., Inc. as applicant

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K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPESK071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENTK071111NON-ABSORBABLE SILK SUTUREK060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIESK042126PICC

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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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