Model 230-06 Cyberlith I Bipolar IN
by Intermedics, Inc. 510(k)
Active
510(k) K811066
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811066 | Date1 May 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Model 230-06 Cyberlith Tm I Bipolar in
- 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
The Model 230-06 Cyberlith I Bipolar IN is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is intended for patients requiring bipolar pacing, providing consistent and reliable stimulation to maintain proper heart function.
This device is supplied sterile and intended for single-use implantation. It is classified under FDA regulation 870.3610 and falls under the traditional 510(k) clearance pathway, with a decision of Substantially Equivalent (SESE) granted in 1981. The Model 230-06 is regulated as a Class III medical device and is used in cardiovascular procedures, adhering to strict manufacturing and quality standards for implantable cardiac devices.