Arrow-Johans ECG Adaptor

• • Terminated Z-2014-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

510(k) Number

K843263 ↗

FDA Product Code

DQY

Device Class

Class II

Regulation

21 CFR Part 870.1250

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Brachial Plexus Catheter - Bp-01200

  Class II

  FDA 510(k) K874105 Active Cleared 24 Nov 1987

• A2 Port, Dual Lumen System With Detached Catheter, Catalog # AP-01518

  Class II

  FDA 510(k) K963684 Active Cleared 24 Oct 1996

• Arrow Picc-Peripherally Inserted Central Catheter

  Class II

  FDA 510(k) K930129 Active Cleared 28 Mar 1994

• Hemosonic 200HEMODYNAMIC Monitor

  Class II

  FDA 510(k) K040802 Active Cleared 28 Apr 2004

• Needleless Injection Cannula

  Class II

  FDA 510(k) K923653 Active Cleared 13 May 1993

• Arrow Echogenic Introducer Needle Component

  Class II

  FDA 510(k) K071998 Active Cleared 26 Sep 2007

See all devices from Arrow Intl., Inc. →

• What is the Arrow-Johans ECG Adapter used for in clinical settings?

  The Arrow-Johans ECG Adapter is designed to transmit right atrial electrocardiographic (RAECG) signals from a catheter’s saline-filled lumen to an external ECG machine. This allows real-time cardiac monitoring during procedures that require access to the right atrium, ensuring continuous assessment of heart activity.

• Is the Arrow-Johans ECG Adapter sterile, and how should it be handled?

  The Arrow-Johans ECG Adapter is supplied as non-sterile, meaning it is intended for single-use in clinical settings where sterility is not a requirement for this specific application. Since it is non-sterile, it should be handled with standard infection control practices, such as washing hands before and after use, and disposed of appropriately after a single procedure.

• How is the Arrow-Johans ECG Adapter connected to a catheter, and what materials is it made of?

  The adapter connects directly to a catheter’s ionic saline-filled lumen to relay electrical signals. It is constructed primarily from stainless steel components, ensuring durability and compatibility with standard ECG monitoring systems while maintaining signal integrity.

• What regulatory pathway was followed for FDA clearance of the Arrow-Johans ECG Adapter?

  The Arrow-Johans ECG Adapter received FDA clearance through the Traditional 510(k) review pathway, specifically under the Cardiovascular (CV) advisory committee. The submission was determined to be substantially equivalent to a predicate device, as indicated by the clearance type (SESE) and the product code (DQY) for catheter adapters.

• Can this adapter be reused, or is it intended for single-use only?

  The Arrow-Johans ECG Adapter is explicitly labeled as single-use only, meaning it should not be reused between patients. This designation aligns with its non-sterile classification and ensures patient safety by preventing potential contamination or signal degradation from repeated use.