Temporary Cardiac Pacing Wire TME 60/61/65
FDA 510(k)Class II (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K831695 FDA 510(k)
- FDA Product Code
- LDF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3680 FDA 510(k)
- Regulation Number
- 870.3680 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Temporary Cardiac Pacing Wire TME 60/61/65 is a temporary cardiac pacing electrode designed for short-term myocardial pacing and sensing. It facilitates temporary cardiac stimulation during and following cardiac surgical procedures, ensuring consistent pacing and sensing while minimizing myocardial trauma. The device supports unipolar, bipolar, and quadripolar configurations for atrial and ventricular pacing applications.
This device is supplied as a single-use, non-sterile product intended for use in cardiac surgical settings. It is compatible with Oscor’s external pacemakers and connection cables. The Temporary Cardiac Pacing Wire TME 60/61/65 holds a FDA 510(k) clearance (K831695) under the Traditional 510(k) Review pathway, classified as a Class II medical device (LDF product code). Sterilization and MRI safety specifications are not detailed in the provided data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Temporary pacing lead wires and myocardial heartwires - OSCOR, PDF Temporary pacing lead wires & myocardial heartwires - OSCOR, TEMP. CARDIAC PACING WIRE TME 60/61/65 510(k) K831695 - FDA.report, Oscor Inc,Cardiac stimulation lead / monopolar TME 60 61 Oscor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K831695 | Class II | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K831695 24 fields · synced Sep 19, 2026