Generators, Atrial Inhibited Pulse
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K780327 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is an Implantable Pacemaker Pulse-Generator, designed to deliver electrical impulses to the heart. It operates with atrial inhibition, meaning it synchronizes pacing with the patient’s natural atrial activity to improve cardiac rhythm management in conditions such as bradycardia or heart block.
The device is intended for surgical implantation and is classified as Class III under FDA regulations. Supplied sterile and intended for single-use, it requires proper handling and storage as specified in manufacturer instructions. Authorized under FDA 510K clearance (K780327), it adheres to regulatory standards for cardiovascular implantable devices.
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 | K780327 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K780327 24 fields · synced Oct 6, 2026