Ep Deflectable Catheters
FDA 510(k) K033963 · Ep Medsystems, Inc.
510(k) numberK033963
Submission
- Device name
- Ep Deflectable Catheters
- Applicant
- Ep Medsystems, Inc.
West Berlin, NJ, US - Received
- December 22, 2003
- Decision date
- April 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code DRF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252794 | Vision-MR Diagnostic CatheterDRF · Traditional | Imricor Medical Systems, Inc. | 01/08/2026SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | Stereotaxis, Inc. | 07/23/2025SE |
| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 06/27/2025SE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional | Boston Scientific Corporation | 11/01/2024SE |
| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
| K233397 | Cosine-10TM Diagnostic CatheterDRF · Traditional | Medtronic, Inc. | 12/02/2023SE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 10/27/2023SE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 09/29/2023SE |
| 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 |
|---|---|---|
| K092913 | EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04JOQ · Special | 10/16/2009SE |
| K073709 | Modification to Viewmate SystemIYN · Special | 03/11/2008SE |
| K071028 | Viewmate SystemITN · Special | 05/01/2007SE |
| K070706 | Ep-WorkmateDQK · Special | 04/11/2007SE |
| K063277 | MapmateDQK · Special | 11/30/2006SE |
| K063113 | Ep-WorkmateDQK · Special | 10/27/2006SE |
| K041442 | EP-4 Clinical StimutatorJOQ · Special | 09/14/2004SE |
| K040207 | EP-4 Clinical StimulatorJOQ · Special | 02/27/2004SE |
| K031066 | Viewmate Ultrasound Imaging SystemIYN · Traditional | 10/17/2003SE |
| K032225 | Ep-Workmate with RPM SystemDQK · Special | 08/20/2003SE |
Questions and answers
When was Ep Deflectable Catheters cleared by the FDA?
Ep Deflectable Catheters (K033963) received a 510(k) decision of Substantially Equivalent on April 15, 2004, 115 days after the submission was received.
What is the product code of K033963?
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.