Easi Lead System Cable Assembly
by Totemite Medical Electronics
510(k) K872781
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872781 | Date29 Dec 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2350
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Easi Lead System Cable Assembly is an adaptor, lead switching device for electrocardiograph monitoring, designed to facilitate the connection and management of multiple cardiac leads in cardiovascular applications. It serves as an intermediary between pacing leads, sensing leads, and external monitoring equipment, ensuring stable and reliable signal transmission for diagnostic and therapeutic purposes.
This device is supplied as a reusable component, intended for use in clinical settings such as hospitals and cardiac care units. It is classified under FDA regulation 870.2350 and holds a Traditional 510(k) clearance (K872781) with a decision date of December 29, 1987. The assembly is categorized under product code DRW and is intended for use in cardiovascular procedures, adhering to established safety and performance standards for electrocardiographic adaptors.