Permanent Pacemaker Electrode
510(k) K905300
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905300 | Date7 May 1991 | 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- Withdrawn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
- Full name
- Permanent Pacing Lead
- 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 under product code DTB, designed for long-term cardiac pacing. It delivers electrical impulses to regulate heart rhythm in patients requiring chronic pacing support, with compatibility for endocardial or epicardial implantation. The lead incorporates an IS-1 compatible connector for interfacing with IS-1 pulse generators, ensuring reliable signal transmission and pacing functionality.
The Permanent Pacemaker Electrode is intended for single-use implantation within the cardiovascular system, adhering to sterile surgical protocols. Supplied as a sterile, implantable device, it is regulated under FDA 510(k) clearance (K905300) and falls under Class III medical device classification. Compatible sizes and configurations are determined by the manufacturer’s specifications, with no additional regulatory or MRI safety restrictions stated in the data. Authorized for use in clinical settings requiring permanent cardiac pacing solutions.
Other devices from Oscor Medical Corp.
Questions
AI-generated answers, 18 Sep 2026
What types of heart locations can this permanent pacing lead be implanted in, and how does it connect to the pacemaker?
This permanent pacing lead is designed for both endocardial (inside the heart chamber) and epicardial (outside the heart, on the surface) implantation. It connects to the pacemaker via an IS-1 compatible connector, ensuring reliable electrical signal transmission for chronic pacing support.
Is this device intended for reuse, or is it meant to be implanted once and left in place permanently?
The device is single-use for implantation—once placed in the cardiovascular system, it is intended to remain in place as a permanent solution for chronic cardiac pacing. It must be handled under sterile surgical conditions.
What regulatory pathway does this device follow, and what class does it belong to under FDA guidelines?
This permanent pacing lead follows the FDA 510(k) clearance pathway (K905300) and is classified as a Class III medical device due to its role in life-sustaining or life-supporting functions. It was determined *substantially equivalent* to a predicate device by the FDA’s Cardiovascular (CV) advisory committee.
Are there any special storage requirements for this lead before implantation?
The device is supplied sterile and must be stored according to manufacturer guidelines to maintain sterility. Since it is intended for direct implantation, it should be kept in its original packaging until use, following standard sterile surgical protocols.
Does this lead have any known compatibility restrictions with MRI machines or other imaging modalities?
The provided data does not mention any MRI safety restrictions or compatibility concerns for this lead. However, final MRI safety should always be confirmed with the manufacturer’s instructions, as individual models or configurations may vary.