Continuous Epidural Anesth. Kits W/Nylon Catheters

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

510(k) Number

K873943 ↗

FDA Product Code

CAZ

Device Class

Class II

Regulation

21 CFR Part 868.5140

Advisory Committee

Anesthesiology

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 primary use case for these continuous epidural anesthesia kits with nylon catheters?

  These kits are designed specifically for continuous epidural anesthesia administration, enabling sustained pain relief during extended surgical or obstetric procedures. The nylon catheters facilitate long-term placement for regional anesthesia, ensuring reliable delivery of anesthetic agents over time.

• Are these kits intended for single-use or reusable applications?

  The kits are strictly for single-use only in clinical settings. The manufacturer emphasizes sterility and proper handling as critical for safe use, explicitly stating they are not intended for reuse to prevent contamination or infection risks.

• How were these kits evaluated and approved by the FDA?

  These kits received FDA 510(k) clearance under the Traditional pathway, meaning they were determined to be substantially equivalent to a legally marketed predicate device. The clearance was granted under product code CAZ and regulation 868.5140, classifying them as Class II medical devices for anesthesiology use.

• What special handling or storage considerations apply to these kits?

  Since the kits are sterile and single-use, they must be stored in a way that maintains sterility until use. The manufacturer does not specify storage conditions in the provided data, but standard practices for sterile medical devices—such as keeping them in sealed packaging, away from moisture or contamination, and at room temperature—should be followed to ensure integrity.