Heparin Bonding for Catheters

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K884697 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Adapter Kit

  Class II

  FDA 510(k) K781864 Active Cleared 19 Dec 1978

• Pacemaker, Perm. & Temp., Electrode

  Class III

  FDA 510(k) K772197 Active Cleared 30 Jan 1978

• Permanent Lead Intraducer

  Class II

  FDA 510(k) K800356 Active Cleared 28 May 1980

• Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K800352 Active Cleared 28 May 1980

• Daig Pacel(Tm) Flow Directed Pacing Catheter

  Class II

  FDA 510(k) K890794 Active Cleared 20 Jun 1989

• Unipolar Lead Configuration Conductor

  Class III

  FDA 510(k) K800348 Active Cleared 28 May 1980

See all devices from Daig Corp. →

• What is the primary purpose of heparin bonding on catheters, and how does it differ from standard catheters?

  Heparin bonding for catheters is a surface treatment that covalently attaches heparin—a natural anticoagulant—to the catheter material. This creates an anticoagulant surface designed to reduce the risk of clot formation (thrombogenesis) and help maintain lumen patency during use. Unlike standard catheters, which rely on systemic anticoagulation or periodic flushing, heparin-bonded catheters provide localized anticoagulation directly on the catheter surface, minimizing clot risk throughout the procedure.

• Is this heparin bonding treatment applied to all catheter types, or are there specific catheter models or sizes it’s used on?

  The heparin bonding treatment is applied as a pre-coated modification to catheters, but the specific models and sizes aren’t detailed in the provided data. However, the device is regulated under 21 CFR 870.3680 and associated with OpenFDA registration numbers (e.g., 3002618605, 3008377825), which suggest it’s intended for a range of cardiovascular catheters, including those listed under the DTB (Catheters, Intravascular) product code. For exact sizes or models, refer to Daig Corp.’s product catalog or technical specifications.

• How is the heparin-bonded catheter supplied, and is it intended for single-use or reusable applications?

  The heparin bonding treatment is supplied as a pre-coated, single-use modification on catheters. This means each catheter is designed for one-time use only, as the heparin coating is applied directly to the surface and cannot be reapplied or reused. Single-use ensures sterility and consistency, reducing the risk of contamination or degradation of the anticoagulant properties over multiple uses.

• What regulatory pathway was followed for FDA clearance of this heparin-bonding treatment, and what does that mean for clinicians?

  The heparin bonding treatment for catheters received FDA 510(k) clearance (K884697) under the Traditional 510(k) pathway, with a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means the device was compared to a legally marketed predicate (likely a similar catheter technology) and deemed to have the same intended use, indications, and risks. Clinically, this clearance indicates the treatment has undergone rigorous review for safety and effectiveness in reducing thrombogenic risk in cardiovascular applications.

• Are there any special storage requirements for heparin-bonded catheters, and how should they be handled to maintain efficacy?

  While the data doesn’t specify exact storage conditions, heparin-bonded catheters—like most sterile medical devices—should be stored in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight to preserve sterility and the integrity of the heparin coating. Follow the manufacturer’s instructions for packaging (e.g., sealed pouches) and expiration dates. Avoid exposing them to chemicals or contaminants that could degrade the anticoagulant properties before use.