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Vascular Products Implantable Pacing

FDA 510(k)

Class III (US FDA 510(k))

510(k) K830950

by Oscor Inc.

Identifiers

510(k) Number
K830950 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, classified as an implantable vascular product designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for use in patients requiring chronic cardiac pacing to manage bradycardia or other conduction disorders, ensuring proper synchronization of heart contractions through direct myocardial stimulation.

The device is supplied sterile and intended for single-use implantation, adhering to Class III regulatory standards under FDA 510(k) clearance (K830950). It is manufactured under the regulation number 870.3680 and distributed in sterile packaging for surgical implantation by trained professionals in clinical settings. Compatibility with MRI environments is not specified, and sizes are determined by the listed FEI numbers (e.g., 3002618605, 1028232). Storage must comply with manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

What clinical conditions is this device designed to address in patients requiring chronic cardiac support?

This device is a Permanent Pacemaker Electrode intended for patients with chronic bradycardia or conduction disorders that disrupt normal heart rhythm. It delivers electrical impulses directly to the heart muscle to maintain proper synchronization of contractions, ensuring reliable cardiac pacing for long-term use.

How is this device packaged and prepared for surgical use, and what does that mean for the clinical workflow?

The device is supplied sterile in sealed packaging, designed exclusively for single-use implantation. This ensures sterility and eliminates the need for reprocessing, simplifying the clinical workflow by allowing immediate use after opening the sterile barrier. Only trained professionals should handle and implant it in controlled surgical settings.

Are there different sizes or models available, and how do I determine which one to select for a patient?

Yes, this device comes in multiple sizes, identified by unique FEI numbers (e.g., 3002618605, 1028232). The correct size should be chosen based on the patient’s anatomical requirements and the specific pacing lead design, typically guided by the implanting physician’s assessment of the patient’s venous access and myocardial target area.

What storage requirements must be followed to ensure the device remains functional and sterile until use?

The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. This includes maintaining the sealed packaging, protecting it from physical damage, and adhering to temperature and humidity controls specified by Oscor Inc. to avoid compromising the device’s integrity before implantation.

Is this device compatible with MRI environments, and if not, what precautions should be taken?

The device’s compatibility with MRI environments is not specified in the provided data, meaning it may not be safe for use in MRI settings. Clinicians should consult the manufacturer’s instructions and consider alternative imaging modalities or MRI-safe pacing systems if MRI is required for the patient. Always verify compatibility before exposing the patient to MRI.

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

United States Active

FDA_510K

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Manufacturer

Manufacturer
Oscor Inc.
FDA Applicant
Oscor, Inc.

Sources (1)

  • FDA 510(k) K830950 24 fields · synced Sep 18, 2026