PressureWire™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: PressureWire™ FDA UDI
Generic Name: Catheter-tip transducer, pressure FDA UDI
Device Name: Signal Receiver Kit FDA UDI
Model / Reference: C17040 FDA UDI
Description: Signal Receiver Kit FDA UDI

Identifiers

Catalog Number: C17040 FDA UDI
Primary DI / UDI-DI: 05415067000118 FDA UDI
FDA Product Code: DXO FDA UDI
DQX FDA UDI
DRG FDA UDI
GMDN Term: Catheter-tip transducer, pressure FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2870 FDA UDI
870.1330 FDA UDI
870.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Catheter-tip transducer, pressure

PressureWire™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
OptoWire — Opsens · Class II
OptoWire — Opsens · Class II
PrimeWire Prestige Pressure Guide Wire 185cm JTIP — Volcarica S.R.L. · Class II
PressureWire™ — LIGHTLAB IMAGING, INC. · Class II
PrimeWire Prestige Pressure Guide Wire 185cm ST — Volcarica S.R.L. · Class II
ACIST Navvus® Catheter — ACIST Medical Systems, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI c1b6a1cf-0125-4866-b479-a0fe2d818efb 36 fields · synced Jun 6, 2026