Identity
- Trade Name
- LEADWIRE EUDAMEDAMC FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- RADIOLUCENT ECG LEADWIRES EUDAMEDECG LEAD WIRES, 3 LEAD SET, RT CARBON, AHA, 30 IN FDA UDI
- Model / Reference
- KT-RTR5730 EUDAMED590485 FDA UDI
- Description
- ECG LEAD WIRES, 3 LEAD SET, RT CARBON, AHA, 30 IN FDA UDI
Identifiers
- Catalog Number
- KT-RTR5730 FDA UDI
- Primary DI / UDI-DI
- 00849593018210 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849593018210 EUDAMED
- 510(k) Number
- K992524 FDA UDI
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- C020599,Z12050380 EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
The LEADWIRE medical device is a Class I, implantable, leadless ECG catheter for the treatment of supraventricular tachycardia. It features a unique design with a flexible wire wrapped around a silicone outer sheath, allowing for precise placement in the heart.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00849593018210 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advantage Medical Electronics LLC
- EUDAMED SRN
- US-MF-000008512
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d4756bea-b2e4-4c64-b88e-278f770aa260 61 fields · synced Jul 9, 2026
- FDA UDI 56204420-45fd-4229-9f9f-d18796c6aa3b 36 fields · synced May 30, 2026