← Back to catalogue

SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP - 119 684

FDA 510(k)

Class III (US FDA 510(k))

510(k) K980869

by Biotronik, Inc.

Identifiers

510(k) Number
K980869 FDA 510(k)
FDA Product Code
DTB FDA 510(k)
Models / Variants
120 444 FDA 510(k)
119 684 FDA 510(k)
120 438 FDA 510(k)
120 143 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

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K980869 24 fields · synced Oct 6, 2026