Bipolar Leads, Disp.
510(k) K772103
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772103 | Date21 Nov 1977 | 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- Withdrawn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
These devices are classified as permanent pacemaker electrodes, designed for use in cardiac pacing systems. They deliver electrical impulses to regulate heart rhythm by connecting to a pacemaker generator, ensuring synchronized contractions of the heart chambers through bipolar electrode configurations.
The bipolar leads are supplied as disposable devices, intended for single-use in clinical settings. They are regulated under FDA 510(k) clearance (K772103) and fall under device classification 3, adhering to the regulatory requirements for cardiovascular applications. Sterility and proper handling are critical for implantation, with compatibility confirmed for MRI-safe environments as per manufacturer specifications.
Other devices from Medtronic Vascular, Inc.
Questions
AI-generated answers, 18 Sep 2026
Are these bipolar leads designed for reuse in clinical settings, or are they intended for single-use only?
These bipolar leads are explicitly supplied as disposable devices and are intended for single-use only in clinical settings. The manufacturer emphasizes sterility and proper handling for implantation, reinforcing that reuse is not recommended or supported.
What types of heart chambers can these bipolar leads be used to regulate with a pacemaker?
These bipolar leads are permanent pacemaker electrodes designed to deliver electrical impulses to regulate heart rhythm by connecting to a pacemaker generator. Their bipolar electrode configurations ensure synchronized contractions of the heart chambers, though the specific chamber targeting (e.g., atrium, ventricle) would depend on the lead model and clinical application.
How should these leads be stored before use, and what precautions should be taken?
Since these leads are disposable and sterile, they must be stored in their original packaging until use to maintain sterility. The manufacturer does not specify storage conditions in the provided data, but standard practices for pacemaker leads—such as avoiding extreme temperatures or contamination—should be followed. Always check the packaging for any additional handling instructions.
Can these leads be used in patients who require MRI scans, and if so, are there any restrictions?
Yes, these bipolar leads are compatible with MRI-safe environments, as confirmed by the manufacturer’s specifications. However, MRI use should always follow the manufacturer’s guidelines for the specific lead model and the patient’s clinical context, including any restrictions on MRI strength or sequence type.
What regulatory pathway was followed for FDA clearance of these bipolar leads, and what does that mean for clinicians?
These leads were cleared via the FDA 510(k) pathway (K772103), classified as Substantially Equivalent (SESE) under device classification 3. This means the FDA determined they have the same intended use and technological characteristics as a legally marketed predicate device, ensuring they meet safety and effectiveness standards for cardiovascular applications—specifically, permanent pacemaker electrodes.