Disposable Surgical Cable
by Conmed Andover Medical, Inc. 510(k)
Active
510(k) K941839
Overview
The Disposable Surgical Cable is a patient cable, transducer and electrode device used in cardiovascular procedures. It is designed for single-use in surgical settings to connect monitoring equipment to patients.
This device is supplied as a sterile, single-use product and is not intended for reuse. It is classified under product code DSA and received FDA 510(k) clearance on July 27, 1994, with registration number K941839. The device is manufactured by Conmed Andover Medical, Inc. and is regulated under 21 CFR 870.2900.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK941839 | Date27 Jul 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DSA
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2900
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Conmed Andover Medical, Inc.
Questions
What is the Disposable Surgical Cable used for?
The Disposable Surgical Cable is a patient cable, transducer and electrode device specifically designed for cardiovascular procedures. It connects monitoring equipment to patients during surgical settings to ensure accurate patient monitoring.
Is the Disposable Surgical Cable reusable or single-use?
The Disposable Surgical Cable is designed for single-use only and is not intended for reuse. It is supplied as a sterile product to maintain infection control standards in surgical environments.
What is the regulatory status of the Disposable Surgical Cable?
The Disposable Surgical Cable received FDA 510(k) clearance on July 27, 1994, with registration number K941839. It is classified under product code DSA and regulated under 21 CFR 870.2900.
Who manufactures the Disposable Surgical Cable?
The Disposable Surgical Cable is manufactured by Conmed Andover Medical, Inc., located in Haverhill, MA. The company is responsible for producing this device according to regulatory standards.