Unipolar Atrial Temporary Pacing Lead, Model 6492

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

510(k) Number

K944966 ↗

FDA Product Code

LDF

Device Class

Class II

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 26mm Diameter Hancock* Trocar Blade and Tip

  Class I

  FDA 510(k) K882479 Active Cleared 18 Jul 1988

• Intersept*prebypass Filter

  Class II

  FDA 510(k) K883086 Active Cleared 16 Sep 1988

• Intersept*crystalloid Cardioplegia Delivery System

  Class II

  FDA 510(k) K883439 Active Cleared 13 Oct 1988

• Intersept* Prebypass Filter

  Class II

  FDA 510(k) K884244 Active Cleared 5 Dec 1988

• Intersept* Crystalloid Cardioplegia Deliv. System

  Class II

  FDA 510(k) K885154 Active Cleared 22 Feb 1989

• Intersept* Crystalloid Cardioplegia Filter

  Class II

  FDA 510(k) K884390 Active Cleared 21 Dec 1988

See all devices from Medtronic Blood Systems, Inc. →

• What is the primary clinical purpose of the Unipolar Atrial Temporary Pacing Lead, Model 6492, and how long is it intended to be used?

  The Unipolar Atrial Temporary Pacing Lead, Model 6492, is designed specifically for temporary atrial pacing and sensing to regulate atrial contractions when the heart’s natural conduction system is temporarily impaired. It is intended for short-term use only, with a maximum implant duration of seven days or less, making it suitable for acute clinical scenarios where temporary pacing support is required.

• Is the Model 6492 lead reusable or intended for single-use, and how is it supplied?

  The Model 6492 lead is explicitly intended for single-use only and is supplied sterile, ensuring it meets clinical standards for immediate implantation without risk of cross-contamination. This design aligns with temporary pacing procedures where sterility and disposability are critical.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Model 6492 lead received FDA clearance through a 510(k) pathway (K944966), classified as a Class II medical device under regulation 870.3680. The clearance was granted as substantially equivalent to a predicate device, with the submission reviewed by the Cardiovascular (CV) Advisory Committee. This pathway confirms its compliance with U.S. safety and performance standards for temporary pacing leads.

• Are there multiple sizes or models of this lead, or is the Model 6492 a single configuration?

  The provided data does not specify multiple sizes or models for the Model 6492 itself, but the OpenFDA registration numbers indicate it may be part of a broader product line (e.g., variations in catheter length, electrode design, or connector types). For precise sizing or model variations, consult the manufacturer’s technical documentation or catalog, as the Model 6492 is described as a singular unipolar lead design.