Low Profile Plastic Port Detached Catheter System Catalog #1017

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

510(k) Number

K961652 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

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 Low Profile Plastic Port Detached Catheter System Catalog #1017 used for?

  This system is designed for long-term vascular access, allowing repeated medication administration, blood sampling, or parenteral nutrition through a subcutaneous, implanted port and catheter. The low-profile reservoir minimizes visibility and discomfort, making it ideal for patients requiring extended intravenous therapy or central venous access.

• Is the Arrow Low Profile Plastic Port Detached Catheter System Catalog #1017 intended for single-use or reuse?

  The system is explicitly intended for single-use implantation by a healthcare professional. While it is designed for repeated use over extended periods, each system is sterile and meant to be implanted once, reducing infection risks associated with repeated catheterizations.

• How should the Arrow Low Profile Plastic Port Detached Catheter System Catalog #1017 be stored before use?

  The device must be stored in a clean, dry environment prior to use. Proper storage ensures sterility and integrity of the components, including the port, catheter, and associated accessories, which are all included in Catalog #1017.

• Can the Arrow Low Profile Plastic Port Detached Catheter System Catalog #1017 be used in MRI environments?

  Yes, the system is non-magnetic and compatible with MRI environments. However, specific MRI safety guidelines should be followed to ensure patient safety during imaging procedures, as the device may interact with magnetic fields in unpredictable ways if not properly managed.

• What components are included in the Arrow Low Profile Plastic Port Detached Catheter System Catalog #1017?

  Catalog #1017 includes all necessary components for implantation: the low-profile subcutaneous port, the integrated catheter for intravenous or central venous access, and associated accessories required for proper use. These components are packaged together as a complete system.