FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REMOVABLE PATIENT LEADS ECG CABLE
K Number: K132253
·
Decision Dec 16, 2013
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
104
Applicant Total
58
Review Days
150
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- REMOVABLE PATIENT LEADS ECG CABLE
- K Number
- K132253
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2900
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific
- Date Received
- July 19, 2013
- Decision Date
- December 16, 2013
- Product Code
- DSA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSA), ordered by most recent decision date.
Baylis Connector Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
IBP cable Becton Dickinson (2606488); IBP cable Edwards (2606489); IBP cable Abbott, Medex (2606490); IBP cable Utah (2606491); IBP Adapter Cable Draeger 7pin (2607558); IBP Adapter Cable Draeger 10pin (2607559)
FDA 510(k)
FDA Class 2
·Cardiovascular
IBP transducer adapter cable, Argon/BD/Ohmeda, 2m; IBP transducer adapter cable, Draeger 10-pin, 2m; IBP transducer adapter cable, Draeger 7-pin, 2m; IBP transd. adapter cbl, Abbott/Medex, Smiths/TranStar 2m; IBP transducer adapter cable, Baxter/Edwards, 0.3m; IBP transducer adapter cable, Baxter/Edwards, 2m; IBP transducer adapter cable, Argon/BD/Ohmeda, 0.3m; IBP transducer adapter cable, Draeger 10-pin, 0.3m; IBP transducer adapter cable, Draeger 7-pin, 0.3m; IBP transducer adapter
FDA 510(k)
FDA Class 2
·Cardiovascular
SpO2 Extension Cable
FDA 510(k)
FDA Class 2
·Cardiovascular
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC; 989803170181, OR 5-Lead ECG Trunk Cable, AAMI/IEC; M1667A, 6 Lead ECG Trunk, AAMI/IEC 2.7m; M1668A,5 Lead ECG Trunk, AAMI/IEC 2.7m; M1669A,3 Lead ECG Trunk, AAMI/IEC 2.7m; M1949A,5+5 ECG Trunk cable AAMI, IEC 2.7m; M1663A,10 Lead ECG Trunk AAMI/IEC 2m; M1665A, 6+4 Lead ECG Trunk AAMI/IEC 2.7m; M1671A, 3 Leadset, Grabber, AAMI, ICU; M1673A, 3 Leadset, Sn
FDA 510(k)
FDA Class 2
·Cardiovascular
RT Carbon ECG Leads
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Boston Scientific
| K Number | Device Name | ||
|---|---|---|---|
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Apr 8, 2026 | Substantially Equivalent |
| K252910 | Orca Air/Water and Suction Valves | Oct 9, 2025 | Unknown |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Jul 3, 2025 | Substantially Equivalent |
| K250468 | iSLEEVE Introducer Set | Mar 20, 2025 | Substantially Equivalent |
| K242950 | WallFlex Biliary PLUS RX Stent System | Dec 6, 2024 | Unknown |
| K242507 | OBSIDIO Conformable Embolic | Oct 3, 2024 | Substantially Equivalent |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV | Aug 30, 2024 | Unknown |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Apr 29, 2024 | Substantially Equivalent |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | Mar 13, 2024 | Substantially Equivalent |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Nov 28, 2023 | Substantially Equivalent |