Qmplantable Program. Cardiac Pulse Gen. W/Telemetr
510(k) K850252
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850252 | Date4 Apr 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is an Implantable Pacemaker Pulse-Generator, designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when necessary. It is classified as a Class III medical device under FDA regulations, requiring strict pre-market approval due to its life-sustaining or life-supporting nature. The device incorporates programmable features to adjust pacing parameters and includes telemetry capabilities for remote monitoring and data transmission.
The device is intended for implantable use within the human body and is supplied sterile for single-patient use. It is regulated under FDA 510(k) clearance (K850252) and falls under the Cardiovascular advisory committee classification. Storage and handling must comply with sterile medical device protocols, and its design adheres to regulatory standards for implantable cardiac devices, including MRI safety considerations where applicable. No additional regulatory status beyond the provided data is implied.