Zynergy Zolution Electrophysiology Catheter, Model Z50000
FDA 510(k) K991060 · Zcv ,Inc.
510(k) numberK991060
Submission
- Device name
- Zynergy Zolution Electrophysiology Catheter, Model Z50000
- Applicant
- Zcv ,Inc.
Edison, NJ, US - Received
- March 30, 1999
- Decision date
- April 6, 2000
- 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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| 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 |
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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 |
|---|---|---|
| K010099 | Zynergy Z3K Balloon Guided Pacing and Monitoring CatheterLDF · Special | 02/01/2001SE |
| K002603 | Zynergy Balloonpace Balloon Guided Pacing and Monitoring CatheterLDF · Traditional | 01/08/2001SE |
| K003118 | Z2 Balloon Guided Pacing & Pressure Monitoring Catheter, Model Z2-7-02-1-10-0DYG · Traditional | 12/20/2000SE |
| K002481 | Zynergy Featherpace Transvenous Bipolar Catheter, Model 04-X-02-3-10-3LDF · Traditional | 12/07/2000SE |
| K990689 | Zynergy Lock-Sure Single Pass Drainage Catheter, Z10005/7/9LJE · Traditional | 09/03/1999SE |
Questions and answers
When was Zynergy Zolution Electrophysiology Catheter, Model Z50000 cleared by the FDA?
Zynergy Zolution Electrophysiology Catheter, Model Z50000 (K991060) received a 510(k) decision of Substantially Equivalent on April 6, 2000, 373 days after the submission was received.
What is the product code of K991060?
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.