Retrox RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K990483 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
- ST FDA 510(k)
The Retrox RX is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to facilitate cardiac pacing. These electrodes are intended for use with pacemaker systems to stimulate the heart muscle, ensuring proper heart rhythm in patients with bradycardia or other conduction disorders.
These devices are supplied sterile and intended for single-use implantation. They are classified as Class III medical devices under FDA regulations and are subject to traditional 510(k) clearance. The electrodes are available in multiple reference codes (45-JBP, 53-JBP, 53-BP, 60) and are regulated under the product code DTB, adhering to the specifications outlined in 21 CFR 870.3680. Storage and handling must comply with sterile medical device protocols.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K990483 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K990483 24 fields · synced Oct 6, 2026