LDF — Electrode, Pacemaker, Temporary Class II
FDA product code LDF covers "Electrode, Pacemaker, Temporary", a Class II medical device regulated under 21 CFR 870.3680. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LDF
- Device Class
- Class II
- Regulation Number
- 870.3680
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K242863 | bioptimal international pte. | Bioptimal Bipolar Pacing Catheter | June 15, 2025 |
| K251186 | c.r. bard | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | May 15, 2025 |
| K241334 | c.r. bard | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Elec | January 31, 2025 |
| K241199 | shenzhen launch electrical co | Rotatable Connector (5944RL) | January 23, 2025 |
| K242705 | medtronic | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar T | January 17, 2025 |
| K232261 | osypka | TME Temporary Myocardial Electrode | April 26, 2024 |
| K190716 | medtronic | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipol | August 8, 2019 |
| K173923 | ethicon | Temporary Cardiac Pacing Wire | August 2, 2018 |
| K171253 | medtronic | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipol | May 25, 2017 |
| K161873 | st jude medical | Pacel Flow Directed Pacing Catheter | November 22, 2016 |
| K160260 | biotrace medical | Tempo Temporary Pacing Lead | October 25, 2016 |
| K161249 | medtronic | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead | August 19, 2016 |
| K152784 | st jude medical | Pacel Bipolar Pacing Catheters | October 22, 2015 |
| K152633 | edwards lifesciences | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing | October 15, 2015 |
| K140972 | medtronic | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, | June 6, 2014 |
| K072770 | oscor | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | January 22, 2008 |
| K042190 | medtronic vascular | MODEL 6416 TEMPORARY PACING LEAD SYSTEM | September 7, 2004 |
| K040812 | medtronic vascular | DETECT SURGICAL PACING AND MAPPING TOOL | September 2, 2004 |
| K033858 | european custom manufacturing | TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE | July 12, 2004 |
| K032613 | peter m. rothenberg, m.d | TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE | November 20, 2003 |