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FDA 510(k)

CG+ Arrow JACC

K-Number: K161765 · 2016-09-06

ApplicantArrow International, Inc. (Subsidiary of Teleflex
Decision Date2016-09-06
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CG+ Arrow JACC is the device name listed in this FDA 510(k) record. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K161765. 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 CG+ Arrow JACC?

CG+ Arrow JACC is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Arrow International, Inc. (Subsidiary of Teleflex. The 510(k) number is K161765.

When did CG+ Arrow JACC receive FDA 510(k) clearance?

CG+ Arrow JACC received FDA 510(k) clearance on 2016-09-06, under 510(k) number K161765.

Who is the listed applicant for CG+ Arrow JACC?

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

What is the FDA product code for CG+ Arrow JACC?

The FDA product code for CG+ Arrow JACC is LJS.

Other records listing Arrow International, Inc. (Subsidiary of Teleflex as applicant

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.

K180395EZ-IO Intraosseous Vascular Access SystemK163513Arrow Endurance Extended Dwell Peripheral Catheter SystemK161313ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyK160018Arrow Quickflash Arterial Catheterization DeviceK153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSK153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC

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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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