Mikro-Cath Pressure Catheter

FDA UDI

Class II (US FDA UDI)

by Millar LLC.

Identity

Trade Name: Mikro-Cath Pressure Catheter FDA UDI
Generic Name: Catheter-tip transducer, pressure FDA UDI
Device Name: The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound. FDA UDI
Model / Reference: 825-0101 FDA UDI
Description: The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound. FDA UDI

Identifiers

Catalog Number: 825-0101 FDA UDI
Primary DI / UDI-DI: 00868924000205 FDA UDI
510(k) Number: K093111 FDA UDI
FDA Product Code: DXO FDA UDI
GMDN Term: Catheter-tip transducer, pressure FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2870 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

MRI Safety

MR Unsafe FDA UDI

Category: Catheter-tip transducer, pressure

Mikro-Cath Pressure Catheter by Millar LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Millar LLC.

Sources (1)

FDA UDI 2a5b4aff-2b15-48ba-96d1-97e4d9830d8e 36 fields · synced Jun 1, 2026