Maxim PF Models 033-581/033-590

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

510(k) Number

K961118 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

• 100 cm Permanent Pacing Lead Models

  Class III

  FDA 510(k) K911273 Active Cleared 28 Aug 1991

• Pellethan Adhesive on Polyurethane Leads-MODI

  Class III

  FDA 510(k) K893041 Active Cleared 14 Nov 1989

• Optima MPT Model 5281E and Model 5282E

  Class III

  FDA 510(k) K897116 Active Cleared 14 Mar 1990

• Telectronics Pacing Systems Vs-1 to 6mm Upsizing

  Class II

  FDA 510(k) K895971 Active Cleared 22 Feb 1990

• Bifurcated Vs-1 to Vs-1 Lead Adaptor

  Class II

  FDA 510(k) K910112 Active Cleared 25 Feb 1991

• Vs-1 Lead Ext. 033-302, 4.75mm 033-260, 033-458

  Class III

  FDA 510(k) K901402 Active Cleared 12 Jun 1990

See all devices from Telectronics Pacing Systems, Inc. →

• Are these pacemaker electrodes designed for reuse in multiple patients, or are they intended for single-use only?

  The Maxim PF Models 033-581/033-590 are explicitly intended for single-use implantation in clinical settings like hospitals and cardiac care units. Since they are sterile upon supply and meant for direct cardiovascular implantation, reuse would violate aseptic conditions and compromise patient safety.

• What storage conditions should I follow to maintain the sterility of these pacemaker leads?

  The devices are supplied sterile and must be stored under aseptic conditions to preserve sterility. While the packaging specifics aren’t detailed, standard practice for sterile medical devices—such as keeping them in a sealed, dry environment away from direct sunlight or extreme temperatures—should be followed until immediate use.

• How do I confirm these leads comply with FDA requirements for tracking and reporting?

  These electrodes are subject to FDA tracking regulations as part of their 510(k) clearance (K961118) under 21 CFR 870.3680. The manufacturer, Telectronics Pacing Systems, Inc., has assigned multiple FEI numbers (e.g., 3002618605) for lot-specific tracking. Clinicians should verify the lot number against the manufacturer’s records to ensure compliance with FDA-mandated reporting requirements.

• What are the key differences between the Model 033-581 and Model 033-590, and how do I select the right one?

  The provided data does not specify technical differences (e.g., electrode design, lead length, or pacing configurations) between the 033-581 and 033-590 models. Selection should be based on the manufacturer’s technical documentation or consultation with a cardiologist, as these distinctions likely relate to clinical application (e.g., atrial vs. ventricular pacing) or patient-specific anatomy.