PrimeWire Prestige Plus Pressure Guide Wire 185cm ST

FDA UDI

Class II (US FDA UDI)

by Volcarica S.R.L.

Identity

Trade Name: PrimeWire Prestige Plus Pressure Guide Wire 185cm ST FDA UDI
Generic Name: Catheter-tip transducer, pressure FDA UDI
Model / Reference: 9185 FDA UDI

Identifiers

Primary DI / UDI-DI: 00845225001100 FDA UDI
510(k) Number: K111395 FDA UDI
FDA Product Code: DQX FDA UDI
GMDN Term: Catheter-tip transducer, pressure 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Catheter-tip transducer, pressure

This PrimeWire Prestige Plus Pressure Guide Wire 185cm ST catheter-tip transducer is designed to measure invasive pressure in various medical applications, including cardiovascular regulation. With a single-use design and updated version number (9185), it's an ideal tool for healthcare professionals seeking accurate measurements. Available in the Volcarica S.R.L. catalog, this device is exempt from PMMA and sterilization requirements.

Similar devices

Also classified as Catheter-tip transducer, pressure.

ACIST Navvus®II Catheter — ACIST Medical Systems, Inc. · Class II
Mikro-Tip Catheter Pulse Transducer — Millar LLC. · Class II
PressureWire™ — ST. JUDE MEDICAL, INC. · Class II
OptoWire — Opsens · Class II
PressureWire™ — ST. JUDE MEDICAL, INC. · Class II
OptoWire — Opsens · Class II
PressureWire™ — LIGHTLAB IMAGING, INC. · Class II
PressureWire™ — ST. JUDE MEDICAL, INC. · Class II

Cleared under the same submission

K111395 also covers:

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: Volcarica S.R.L.

Sources (1)

FDA UDI a4a1a547-3c1a-4c4b-984f-1f24010d304e 33 fields · synced Jun 28, 2026