Identity
- Trade Name
- QuikCAS EUDAMEDQuikCAS Cardiodrive Sterile Components FDA UDI
- Generic Name
- Cardiac mapping system workstation FDA UDI
- Device Name
- QuikCAS Cardiodrive Sterile Components EUDAMEDThe Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. FDA UDI
- Model / Reference
- III EUDAMED001-001751-1 EUDAMED1 FDA UDI
- Description
- The Stereotaxis Cardiodrive is intended for automatically advancing and retracting only compatible magnetic electrophysiology (EP) mapping and ablation catheters inside the patient's heart when used in conjunction with a Stereotaxis Magnetic Navigation System (MNS). It is not intended to advance the EP mapping and ablation catheters through the coronary vasculature nor the coronary sinus. FDA UDI
Identifiers
- Catalog Number
- 001-001751-1 FDA UDI
- Primary DI / UDI-DI
- M58800100175110 EUDAMEDFDA UDI
- Basic UDI-DI
- ++M588001001751LQ EUDAMED
- 510(k) Number
- K071029 FDA UDI
- FDA Product Code
- DQX FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Cardiac mapping system workstation FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
QuikCAS by Stereotaxis, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++M588001001751LQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stereotaxis, Inc.
- EUDAMED SRN
- US-MF-000026621
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 951f99b1-4d5d-45eb-b0fe-056f22ba07ac 61 fields · synced Jul 23, 2026
- FDA UDI 139f3e68-8462-4244-bed5-58dbd1a43390 37 fields · synced May 30, 2026