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FloWire Doppler Guide Wire XT 175cm 014 JTIP

FDA UDIEUDAMED

Class II (US FDA UDI)

by Volcano Corporation

Identity

Trade Name
FloWire Doppler Guide Wire XT 175cm 014 JTIP FDA UDI
Generic Name
Blood flowmeter catheter, Doppler FDA UDI
Model / Reference
1403J FDA UDI

Identifiers

Primary DI / UDI-DI
00184360000167 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 175cm 014 JTIP by Volcano Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Blood flowmeter catheter, Doppler.

Cleared under the same submission

K972762 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Volcano Corporation

Sources (2)

  • FDA UDI c9318c51-0ef6-4e00-9cb7-76d920ce0774 33 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced May 29, 2026