Panels › Cardiovascular › Product code DSA · Class 2
Cable, Transducer And Electrode, Patient, (Including Connector)
Regulation 870.2900
2510(k)s in 12 months (105 all time)
0recalls in 12 months (12 all time)
6recalls that name a 510(k)
Top companies in DSA
| Company | 510(k)s | Recalls |
|---|---|---|
| GE Healthcare, LLC | 0 | 5 |
| Medtronic Vascular | 5 | 0 |
| Remington Medical, Inc. | 2 | 2 |
| Tronomed, Inc. | 4 | 0 |
| Arbo Medical, Inc. | 3 | 0 |
| Vyaire Medical, Inc. | 3 | 0 |
| Baylis Medical Technologies, Inc. | 2 | 0 |
| Beijing Rongrui-Century Science & Technology Co., Ltd. | 2 | 0 |
| Biosense Webster, Inc. | 1 | 1 |
| Boston Scientific | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2025 | Physio-Control, Inc. LIFEPAK 35 ECG cable REF 11111-000041 Open, Classified |
DSA | K240377 |
| Feb 3, 2022 | Volcano Corp MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems Open, Classified |
DSA | None listed |
| Aug 1, 2019 | GN Otometrics Gold Cup Leadwire and Snap Leadwire with the following component descriptions:
1. 24" Snap Leadwire, Blue;
2. 40" Snap Leadwire, Blue;
3. 24" Snap Leadwire, Red;
4. 40" Snap Leadwire, Red; Open, Classified |
DSA | K080112 |
| Jul 19, 2019 | Philips North America, LLC Philips 5-Lead Set, Disposable, Bedside, AAMI
Model # 989803173131
Product Usage:
Philips Single-Patient-Use ECG lead sets for bedside monitoring are available in 5-lead configuration Terminated |
DSA | K110287 |
| May 10, 2019 | GE Healthcare, LLC Replacement ECG leadwires with snap ends
REF/Catalog Number Description
2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in
The reusable ECG leadwire sets enable ECG monitoring with G Terminated |
DSA | None listed |
| May 10, 2019 | GE Healthcare, LLC Leadwire sets with snap ends:
REF/Catalog Number Description
2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in
2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in
2106381-003 EC Terminated |
DSA | None listed |
| May 10, 2019 | GE Healthcare, LLC Replacement leadwires with grabber ends:
REF/Catalog Number Description
2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in
2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, Terminated |
DSA | None listed |
| May 10, 2019 | GE Healthcare, LLC ECG leadwire sets:
REF/Catalog Number Description
2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in
2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in
Terminated |
DSA | None listed |
| May 10, 2019 | GE Healthcare, LLC ECG Trunk Cables:
REF/Catalog Number Description
2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft.
2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft.
2106305-003 ECG Trunk Cable, 3/5-lead Terminated |
DSA | None listed |
| Apr 9, 2014 | Remington Medical Inc. FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
Electrical extension cable intended to transmit signal from, or power or excitation signal to patient connected electrodes. The Terminated |
DSA | K971968 |
| Jan 7, 2011 | Biosense Webster, Inc. CARTO 3 System Interface Cable, 34-pin to 10-pin, Red, 10' - Part Number: D-1286-18; Catalog Number CR3410CT
This product provides a signal interface between a Biosense Webster electrophysiology cathe Terminated |
DSA | K090017 |
| Aug 13, 2010 | Remington Medical Inc. Disposable Surgical Cable, Product Code: FL-601-97 (100), Single use, Rx Only, Remington Medical, Inc., 6830 Meadowridge Court, Alpharetta, GA 30005
Usage: Temporary pacing of open hearts: used with Terminated |
DSA | K971968 |
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