Implantable Pacing Lead, Tined
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K823446 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 implantation within the cardiovascular system to deliver electrical stimulation to the heart. It facilitates cardiac pacing by transmitting pacing pulses to the myocardium, ensuring proper heart rhythm in patients with bradycardia or conduction disorders. The tined design enhances fixation within cardiac tissue, reducing the risk of dislodgment.
The lead is supplied sterile and intended for single-use implantation during cardiac procedures. It is classified as a Class III medical device under FDA regulations and requires FDA 510(k) clearance for commercial distribution. Compatible with MRI environments under specific conditions (as per manufacturer guidelines), it is available in multiple reference codes for various pacing applications. Storage must adhere to sterile packaging instructions 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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K823446 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K823446 24 fields · synced Sep 18, 2026