AFP Cardiac Pacing System Model 283

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

510(k) Number

K942440 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

• Pacing Lead Model 1188T

  Class III

  FDA 510(k) K925038 Active Cleared 15 Jul 1994

• Silicone Bipolar Lead Models 1136T, 1142T &1146T

  Class III

  FDA 510(k) K930876 Active Cleared 15 Jun 1994

• Adapting Sleeve Kit Model 4023

  Class II

  FDA 510(k) K921318 Active Cleared 3 Aug 1992

• Model 1148T Transvenous, Screw-In Lead

  Class III

  FDA 510(k) K925347 Active Cleared 10 Jun 1993

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K920822 Active Cleared 22 Jan 1993

• Passive Plus Endocardial Pacing Leads Var. Models

  Class III

  FDA 510(k) K932892 Active Cleared 6 Jul 1994

• Is the AFP Cardiac Pacing System Model 283 designed for single-use or can it be reused in multiple patients?

  The AFP Cardiac Pacing System Model 283 is explicitly described as a reusable medical device. Since it is intended for chronic cardiac rhythm management, it is meant to remain implanted in a single patient long-term, not reused across multiple patients. Reusability in this context refers to its durability for prolonged use within one patient’s treatment plan.

• What types of heart conditions is this device intended to address, and how does it work?

  This device is designed for patients with chronic bradycardia or heart block, providing consistent electrical stimulation to maintain proper heart function. It delivers pacing signals to regulate the heart’s rhythm when the natural conduction system fails, ensuring the heart beats at an appropriate rate.

• How is the AFP Cardiac Pacing System Model 283 regulated in the U.S., and what does that mean for clinicians?

  The device holds FDA 510(k) clearance under a *Traditional* review pathway, classified as a Class III device. This means it undergoes rigorous pre-market evaluation to ensure safety and effectiveness for chronic cardiac pacing. Clinicians can rely on its compliance with 21 CFR 870.3680, though it is subject to tracking as part of its regulatory requirements.

• Are there multiple sizes or models of this device, or is it a single standardized unit?

  The provided data does not specify individual sizes or variants of the Model 283, but it references multiple FEI numbers (e.g., 3002618605, 2183787) under the same product code (DTB). These likely correspond to different production lots or batch identifiers rather than distinct physical sizes or models. For precise sizing or model options, consult the manufacturer’s technical documentation.