Identity
- Trade Name
- Cardiodrive Hemostasis Adapter - SJ FDA UDI
- Generic Name
- Cardiac mapping system workstation FDA UDI
- Device Name
- 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
- Model / Reference
- 1 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
- 001-001771-2 FDA UDI
- Primary DI / UDI-DI
- M5880010017712 FDA UDI
- 510(k) Number
- K071029 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Cardiac mapping system workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Cardiac mapping system workstation
Cardiodrive Hemostasis Adapter - SJ by Stereotaxis, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping system workstation.
- CorPath GRX Cassette — Corindus, Inc. · Class II
- CorPath GRX Extended Reach Arm — Corindus, Inc. · Class II
- CorPath GRX Robotic Drive — Corindus, Inc. · Class II
- CorPath GRX Cassette Duo — Corindus, Inc. · Class II
- vMap Disposables — Vektor Medical, Inc. · Class II
- CorPath GRX Drape, Control Console — Corindus, Inc. · Class II
- CorPath GRX Drive Gear — Corindus, Inc. · Class II
- CorPath GRX Extended Reach Arm — Corindus, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Stereotaxis, Inc.
Sources (1)
- FDA UDI c4938256-d743-4060-8928-0ce764bf5737 37 fields · synced Jun 8, 2026