PressureWire™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: PressureWire™ FDA UDI
Generic Name: Cardiac/peripheral vascular guidewire, single-use FDA UDI
Device Name: Guidewire Mounted Sensor FDA UDI
Model / Reference: C12058 FDA UDI
Description: Guidewire Mounted Sensor FDA UDI

Identifiers

Catalog Number: C12058 FDA UDI
Primary DI / UDI-DI: 05414734055772 FDA UDI
510(k) Number: K140466 FDA UDI
FDA Product Code: DRG FDA UDI
DXO FDA UDI
DQX FDA UDI
GMDN Term: Cardiac/peripheral vascular guidewire, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2910 FDA UDI
870.2870 FDA UDI
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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 175 Centimeter FDA UDI

Category: Cardiac/peripheral vascular guidewire, single-use 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

Cleared under the same submission

K140466 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: St. Jude Medical, Inc.

Sources (1)

FDA UDI ff571d38-76e7-4fe3-a2c2-eee52411ba53 38 fields · synced May 30, 2026