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CG+ Arrow JACC

by Arrow International, Inc. (Subsidiary of Teleflex

510(k) K161765

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK161765 Date6 Sep 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LJS
Device Class
Class II
Regulation
21 CFR Part 880.5970
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CG+ Arrow JACC is a radiopaque polyurethane central venous catheter treated with chlorhexidine-based Chlorag+ard technology to reduce microbial colonization and thrombus accumulation. It is classified as a long-term intravascular therapeutic catheter for use greater than 30 days.

The device received FDA 510(k) clearance under K161765 on September 6, 2016, and is manufactured by Arrow International, Inc. (a subsidiary of Teleflex). It is supplied non-sterile and intended for single-use in general hospital settings.

Other devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

See all devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.) →

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the CG+ Arrow JACC?

    This device is a long-term intravascular therapeutic catheter designed for use in general hospital settings for durations exceeding 30 days.

  • How is the CG+ Arrow JACC supplied?

    The catheter is supplied non-sterile and is intended for single-use only to ensure patient safety and prevent cross-contamination.

  • What features help reduce complications with this catheter?

    The catheter is constructed from radiopaque polyurethane and treated with chlorhexidine-based Chlorag+ard technology, which is intended to reduce both microbial colonization and thrombus accumulation on the device.