FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardiodrive System
DI: M58800100411590
·
Model: II
·
STEREOTAXIS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cardiodrive System
- Primary DI
- M58800100411590
- Version / Model
- II
- Catalog Number
- 001-004115-9
- Company Name
- STEREOTAXIS, INC.
- Labeler DUNS
- 024942265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 435e3adf-7212-42f6-b726-885f571cd9dd
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQX | Wire, Guide, Catheter | Cardiovascular | 870.1330 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31742 | Cardiac mapping system workstation | A mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M58800100411590 | HIBCC |
Customer Contacts
- Phone
- 13146786100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071029 | 000 |