Seamed 4000
by Seamed Corp. 510(k)
Active
510(k) K843777
Overview
The Seamed 4000 is an External Pulse-Generator Pacemaker, classified as a Class 2 Cardiovascular device. It is designed to deliver temporary pacing support to patients experiencing bradycardia or other cardiac conduction disorders requiring external cardiac stimulation.
This device is intended for use in clinical settings such as hospitals and cardiac care units, where temporary pacing may be required. Supplied as a reusable medical device, it adheres to FDA clearance (510(k) K843777) under the Traditional pathway. No specific sterility or MRI safety data is provided in the records, and sizes or additional technical specifications are not detailed in the available documentation.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843777 | Date1 Feb 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3600
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Seamed Corp.
Questions
What clinical scenarios is the Seamed 4000 External Pulse-Generator Pacemaker designed to address in patients?
The Seamed 4000 is specifically intended for temporary cardiac pacing support in patients experiencing bradycardia or other cardiac conduction disorders that require external stimulation. This includes settings like hospitals or cardiac care units where temporary pacing is necessary to stabilize heart rhythm until a permanent solution can be implemented.
Is the Seamed 4000 a single-use or reusable device, and what does that mean for its maintenance?
The Seamed 4000 is classified as a reusable medical device, meaning it is designed for repeated use within a clinical setting after proper cleaning, disinfection, and maintenance procedures. This allows hospitals to rely on the same unit for multiple patients over time, provided they follow manufacturer guidelines for reprocessing.
How was the FDA clearance for the Seamed 4000 determined, and what does that mean for its regulatory standing?
The Seamed 4000 received FDA clearance under the Traditional 510(k) pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it met the same performance standards as an existing, legally marketed device in the same category (External Pulse-Generator Pacemaker, Class 2). The clearance was granted in 1985, and the device remains compliant with FDA regulations for cardiovascular devices.
Are there any specific storage requirements or considerations for the Seamed 4000 before use?
The available documentation does not specify sterility or storage conditions for the Seamed 4000, so it is critical to follow the manufacturer’s (Seamed Corp.) instructions for handling and storage. Since it is reusable, proper maintenance—including cleaning, disinfection, and environmental controls—will be essential to ensure safe, repeated use in clinical settings.