Implantable Electrode Lead 030-271 Using Polyureth
510(k) K851295
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK851295 | Date10 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- Withdrawn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
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed for implantation within the cardiovascular system to facilitate electrical signal transmission for cardiac pacing applications, ensuring proper heart rhythm regulation in patients requiring chronic pacing support.
The Implantable Electrode Lead 030-271 is supplied sterile and intended for single-use implantation. Constructed using polyurethane, it is intended for use in MRI-unspecified environments unless otherwise specified by the manufacturer. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE) as reviewed by the Cardiovascular Advisory Committee. Storage and handling must comply with sterile medical device protocols.