Weck Cardiac Pacing Wires
510(k) K011660
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011660 | Date21 Aug 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LDF
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Weck Cardiac Pacing Wires are temporary epicardial pacing electrodes designed for post-cardiac surgery pacing support. These devices deliver electrical stimulation to the heart via a curved stainless steel needle attached to a fluoropolymer-coated stainless steel braided wire, ensuring reliable pacing functionality during recovery periods. The distal end is uninsulated to facilitate direct conduction of pacing signals, while the proximal end features a Keith or Milner breakaway needle for secure placement.
These wires are supplied as single-use devices and are intended for use in cardiac surgical settings. They are not sterile at the time of shipment but are packaged in a manner suitable for sterilization prior to use. The devices are classified as Class II under FDA regulations (870.3680) and have received FDA 510(k) clearance (K011660) as substantially equivalent to predicate devices. Variations include color-coded insulation (white/orange) to differentiate atrial and ventricular leads, though this does not affect functionality or regulatory compliance.
Other devices from Weck Closure Systems
Questions
AI-generated answers, 1 Oct 2026
What is the Weck Cardiac Pacing Wire designed for?
The Weck Cardiac Pacing Wire is designed for temporary epicardial pacing support following cardiac surgery. It delivers electrical stimulation to the heart via a curved stainless steel needle attached to a fluoropolymer-coated stainless steel braided wire, ensuring stable pacing during recovery. The uninsulated distal end facilitates direct conduction, while the proximal end includes a Keith or Milner breakaway needle for secure placement.
Are these pacing wires sterile at the time of shipment?
No, the Weck Cardiac Pacing Wires are not sterile at the time of shipment. They are packaged in a manner suitable for sterilization prior to use, making them suitable for sterile surgical environments when properly processed.
How are the atrial and ventricular leads differentiated?
The atrial and ventricular leads are differentiated by color-coded insulation—white for atrial leads and orange for ventricular leads. This color-coding is purely for identification and does not affect the functionality or regulatory compliance of the device.
Are these pacing wires single-use or reusable?
The Weck Cardiac Pacing Wires are intended for single-use only. They are designed to be discarded after a single procedure to ensure patient safety and maintain sterility standards.
What regulatory classification and clearance does this device hold?
The Weck Cardiac Pacing Wires are classified as Class II devices under FDA regulations (870.3680) and have received FDA 510(k) clearance (K011660) as substantially equivalent to predicate devices. This clearance confirms their compliance with FDA standards for temporary cardiac pacing electrodes.