FDA 510(k)

PERIPHERALLY INSERTED MEDLINE CATHETER

K-Number: K963257 · 1997-03-04

Decision Date1997-03-04

Product CodeLJS

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PERIPHERALLY INSERTED MEDLINE CATHETER 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 1997-03-04 under 510(k) number K963257. 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 PERIPHERALLY INSERTED MEDLINE CATHETER?

PERIPHERALLY INSERTED MEDLINE CATHETER is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K963257.

When did PERIPHERALLY INSERTED MEDLINE CATHETER receive FDA 510(k) clearance?

PERIPHERALLY INSERTED MEDLINE CATHETER received FDA 510(k) clearance on 1997-03-04, under 510(k) number K963257.

Who is the listed applicant for PERIPHERALLY INSERTED MEDLINE CATHETER?

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 PERIPHERALLY INSERTED MEDLINE CATHETER?

The FDA product code for PERIPHERALLY INSERTED MEDLINE CATHETER is LJS.

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Other records listing Arrow Intl., Inc. as applicant

K100635ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504 K093050ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520 K071491ARROW INTERNATIONAL, INC., SURGICAL DRAPES K071998ARROW ECHOGENIC INTRODUCER NEEDLE COMPONENT K071111NON-ABSORBABLE SILK SUTURE K060309AUTOCAT INTRA-AORTIC BALLOON PUMP SERIES

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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.