SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP - 120 143
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K980869 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)
The Synox SX series are Permanent Pacemaker Electrode leads, classified as Class III devices under FDA regulations. These bipolar pacing and sensing leads are designed for endocardial placement, providing passive fixation for reliable electrical connection in cardiac rhythm management applications. Available in both straight (SX xx-BP) and J-shaped (SX xx-JBP) configurations, they support ventricular and atrial pacing requirements.
These leads are intended for single-use implantation with implantable pulse generators and are regulated under FDA 510(k) clearance (K980869) as substantially equivalent to predicate devices. Supplied sterile, they require surgical implantation by qualified medical professionals in controlled clinical settings. The models include distinct lead lengths and configurations (e.g., 120 444, 119 684) to accommodate varying patient anatomies and procedural needs.
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: Synox Sx 53-bp, Sx 60-bp, Sx 45-jbp, Sx 53-jbp , Models 120 444, 119 ..., Synox Sx 53-bp, Sx 60-bp, Sx 45-jbp, Sx 53-jbp , Models 120 444, 119 ..., PDF K980869 - Synox Sx 53-bp, Sx 60-bp, Sx 45-jbp, Sx 53-jbp , Models 120 ..., synox sx 53-bp sx 60-bp sx 45-jbp sx 53-jbp models 120 444 119 684 120 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K980869 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik, Inc.
Sources (1)
- FDA 510(k) K980869 24 fields · synced Oct 6, 2026