Permanent Implantable Fh Endocardial Leads W/Tip
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K910608 FDA 510(k)
- FDA Product Code
- DTB FDA 510(k)
Classification
- Device Class
- Class III 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)
This device is a Permanent Pacemaker Electrode, designed for endocardial implantation to facilitate cardiac pacing. The leads are intended to deliver electrical stimulation to the heart’s endocardium, supporting rhythm regulation in patients with bradycardia or conduction disorders. Constructed for long-term use, they are engineered to interface with implantable pulse generators for sustained cardiac function.
The leads are supplied sterile and intended for single-use implantation by qualified medical professionals in clinical settings. They are classified as Class III devices under FDA regulations and are authorized via 510K clearance (K910608). Multiple model references are available, ensuring compatibility with various pacemaker systems. Storage and handling must adhere to sterile procedures to maintain integrity prior to use.
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: Permanent. Wirtschaftsförderung // Werbeagentur
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K910608 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biotronik, GmbH & Co.
Sources (1)
- FDA 510(k) K910608 24 fields · synced Sep 18, 2026