Model 4280 Surgical Extension Cable
FDA 510(k) K922899 · Pace Medical
510(k) numberK922899
Submission
- Device name
- Model 4280 Surgical Extension Cable
- Applicant
- Pace Medical
Waltham, MA, US - Received
- June 16, 1992
- Decision date
- December 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K243545 | Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171…DSA · Traditional | Philips Medizin Systeme Böblingen GmbH | 01/17/2025SE |
| K240087 | RT Carbon ECG LeadsDSA · Traditional | Ivy Biomedical Systems, Inc. | 09/13/2024SE |
| K240377 | LIFEPAK® ECG CablesDSA · Traditional | Stryker Physio-Control | 05/07/2024SE |
| 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 |
More from Baylis Medical Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011980 | Adapter, Pacing Analyzer/Universal Pacing Adapter, Models 4820 and 4825DTE · Traditional | 09/12/2001SE |
| K012392 | Disposable Surgical Extension Cable, Model 4255 and Model 4260DSA · Traditional | 09/04/2001SE |
| K002204 | Pacemaker Extension Cable Models 4265,4265A, 4265V, 5265, 5265A, 5265VDTE · Traditional | 10/18/2000SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | 10/10/2000SE |
| K002496 | Model 4815 AdapterDTN · Traditional | 10/10/2000SE |
| K001180 | Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker…DTE · Traditional | 06/27/2000SE |
| K925143 | Model 4800 Accupace Pacing System AnalyerDTE · Traditional | 09/27/1994SE |
| K931662 | Lead Introducer Set, Various Models and SizesDYB · Traditional | 08/31/1993SE |
| K913805 | Miniature Models 4562/4563/4572/4573 PacemakerDTE · Traditional | 11/19/1991SE |
| K913134 | Model 4220DXY · Traditional | 08/22/1991SE |
Questions and answers
When was Model 4280 Surgical Extension Cable cleared by the FDA?
Model 4280 Surgical Extension Cable (K922899) received a 510(k) decision of Substantially Equivalent on December 23, 1992, 190 days after the submission was received.
What is the product code of K922899?
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.