Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable
FDA 510(k) K011847 · Zynergy Cardio Vasular (Zcv), Inc.
510(k) numberK011847
Submission
- Device name
- Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable
- Applicant
- Zynergy Cardio Vasular (Zcv), Inc.
Edison, NJ, US - Received
- June 13, 2001
- Decision date
- July 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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 |
Questions and answers
When was Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable cleared by the FDA?
Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable (K011847) received a 510(k) decision of Substantially Equivalent on July 13, 2001, 30 days after the submission was received.
What is the product code of K011847?
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.