510(k) K251186
- Device
- Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- Applicant
- C.R. Bard, Inc.
- 510(k) number
- K251186
- Product code
- LDF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-15
- Date received
- 2025-04-16
- Regulation
- 870.3680
- Classification name
- Electrode, Pacemaker, Temporary
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Caitlin Bowles
- Address
- 8195 Industrial Blvd. Covington GA US 30014 30014
FDA Registration Numbers
- 3004091615
- 9611665
- 2134812
- 1450662
- 2024311
- 1018233
- 2648623
- 3012179728
- 9673241
- 1061124
- 3011163668
- 3035372913
- 1313046
- 2135338
- 2648650
- 2015691
- 2184009
- 3007770159
- 3010041511
- 3014255018
- 3012536737
- 1043214
- 3035111606
- 3004785273
- 2648045
- 3003955307
- 3003289723
- 1018470
- 3017060084
- 2032112
- 3015173212
- 3017896194
- 3013288201
- 2242056
- 3008496528
- 2025587
- 8043983
- 2182269
- 3010532612
- 3015225571
- 3006638824
- 3006082230
- 3005012805
- 3017102971
- 1035166
- 9611350
- 3011137372
- 2024168
- 3015309643
- 3004365956
- 1650907
- 3032916632
- 2011171
- 3008061490
- 1928237
- 1721676
- 1721504
- 2939561
- 3027815
- 2182208
- 1721686
- 3018094310
- 3015859709
- 3006950086
- 3033589330
- 1319639
- 1317547
- 2210968
- 3013162291
- 3003923762
- 1061927
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code LDF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242863 | Bioptimal Bipolar Pacing Catheter | Bioptimal International Pte. , Ltd. | 2025-06-15 |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, | C.R. Bard, Inc. | 2025-01-31 |
| K241199 | Rotatable Connector (5944RL) | Shenzhen Launch Electrical Co., Ltd. | 2025-01-23 |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) | Medtronic, Inc. | 2025-01-17 |
| K232261 | TME Temporary Myocardial Electrode | Osypka AG | 2024-04-26 |
| K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead | Medtronic | 2019-08-08 |
| K173923 | Temporary Cardiac Pacing Wire | ETHICON, Inc. | 2018-08-02 |
| K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead | Medtronic | 2017-05-25 |
| K161873 | Pacel Flow Directed Pacing Catheter | St Jude Medical | 2016-11-22 |
| K160260 | Tempo Temporary Pacing Lead | Biotrace Medical, Inc. | 2016-10-25 |
| K161249 | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead | Medtronic | 2016-08-19 |
| K152784 | Pacel Bipolar Pacing Catheters | St Jude Medical | 2015-10-22 |
| K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe | Edwards Lifesciences, LLC | 2015-10-15 |
| K140972 | UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING | Medtronic, Inc. | 2014-06-06 |
| K072770 | TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) | Oscor, Inc. | 2008-01-22 |