Permanent Pacing Lead, Model PY2
FDA 510(k)Class III (US FDA 510(k))
by Oscor Inc.
Identifiers
- 510(k) Number
- K041809 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 Permanent Pacing Lead, Model PY2, is a Permanent Pacemaker Electrode, a Class III medical device designed for transvenous implantation in the heart. It delivers electrical stimulation to regulate cardiac rhythm in patients with bradycardia or conduction disorders, ensuring consistent pacing support through its conductive tip and secure fixation mechanisms.
This lead is intended for single-use implantation by qualified healthcare professionals in sterile operating or electrophysiology laboratory settings. Supplied sterile and packaged for surgical use, it adheres to FDA 510(k) clearance (K041809) under the Special clearance type, with regulatory classification under 870.3680. Compatibility with MRI environments is not specified, and sizing is determined by manufacturer specifications for transvenous placement.
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 | K041809 | Class III | Active |
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Manufacturer
- Manufacturer
- Oscor Inc.
- FDA Applicant
- Oscor, Inc.
Sources (1)
- FDA 510(k) K041809 24 fields · synced Sep 18, 2026