Identity
- Trade Name
- FloWire Doppler Guide Wire XT 300cm 014 ST FDA UDI
- Generic Name
- Blood flowmeter catheter, Doppler FDA UDI
- Model / Reference
- 1413 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00184360000198 FDA UDI
- 510(k) Number
- K972762 FDA UDI
- FDA Product Code
- DQX FDA UDI
- GMDN Term
- Blood flowmeter catheter, Doppler 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood flowmeter catheter, Doppler
FloWire Doppler Guide Wire XT 300cm 014 ST by Volcano Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood flowmeter catheter, Doppler.
- Cook-Swartz — COOK VANDERGRIFT INC. · Class II
- Cook-Swartz — COOK VANDERGRIFT INC. · Class II
- FloWire Doppler Guide Wire XT 300cm 014 JTIP — VOLCANO CORPORATION · Class II
- FloWire Doppler Guide Wire XT 175cm 014 JTIP — VOLCANO CORPORATION · 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 |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (1)
- FDA UDI f7ac1cde-0306-4d3c-8237-1b17c4ad8364 33 fields · synced Jun 8, 2026