Tracer O-T-W Mapping Device
FDA 510(k) K972803 · Cardima, Inc.
510(k) numberK972803
Submission
- Device name
- Tracer O-T-W Mapping Device
- Applicant
- Cardima, Inc.
Fremont, CA, US - Received
- July 28, 1997
- Decision date
- May 11, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
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| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | Stereotaxis, Inc. | 07/23/2025SE |
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| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
| K233397 | Cosine-10TM Diagnostic CatheterDRF · Traditional | Medtronic, Inc. | 12/02/2023SE |
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| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional | Boston Scientific | 04/25/2023SE |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 12/30/2022SE |
More from Shanghai Microport EP Medtech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K060715 | Modification to: Cardima Ablation SystemOCL · Special | 05/15/2006SE |
| K022008 | Cardima Ablation SystemOCL · Traditional | 01/29/2003SE |
| K974683 | Naviport Deflectable Tip Guiding CatheterDQY · Traditional | 06/22/1999SE |
| K982835 | Electrode Switchbox, Model 11-081002DRF · Abbreviated | 10/29/1998SE |
| K971975 | Cardima Pathfinder 1.5F Mapping MicrocatheterDRF · Traditional | 07/01/1998SE |
| K973298 | Cardima Vueport Coronary Sinus Balloon Occlusion Guiding CatheterDQY · Traditional | 06/26/1998SE |
| K970853 | Pathfinder 3MM Mapping Microcatheter (01-082001)DRF · Traditional | 11/04/1997SE |
| K955802 | PathfinderDRF · Traditional | 01/29/1997SE |
| K951603 | Cardima, Inc. ForerunnerDQY · Traditional | 10/05/1995SE |
| K932800 | Cardima Tracker(R) Infusion CatheterKRA · Traditional | 12/21/1993SE |
Questions and answers
When was Tracer O-T-W Mapping Device cleared by the FDA?
Tracer O-T-W Mapping Device (K972803) received a 510(k) decision of Substantially Equivalent on May 11, 1999, 652 days after the submission was received.
What is the product code of K972803?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.