Removable Patient Leads ECG Cable
FDA 510(k) K132253 · Boston Scientific
510(k) numberK132253
Submission
- Device name
- Removable Patient Leads ECG Cable
- Applicant
- Boston Scientific
St Paul, MN, US - Received
- July 19, 2013
- Decision date
- December 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
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| K240156 | LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV…DSA · Traditional | Physio-Control, Inc. | 04/30/2024SE |
| K222712 | Fogg System Patient Monitoring CablesDSA · Traditional | Fogg System Company, Inc. | 11/22/2023SE |
| K230571 | RFP-100A Connector Cable (Single Use)DSA · Traditional | Baylis Medical Technologies, Inc. | 05/30/2023SE |
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Questions and answers
When was Removable Patient Leads ECG Cable cleared by the FDA?
Removable Patient Leads ECG Cable (K132253) received a 510(k) decision of Substantially Equivalent on December 16, 2013, 150 days after the submission was received.
What is the product code of K132253?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.