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Pioneer Plus Catheter

FDA UDI

Class II (US FDA UDI)

by Philips Image Guided Therapy Corporation

Identity

Trade Name
Pioneer Plus Catheter FDA UDI
Generic Name
Intravascular ultrasound imaging catheter, single-use FDA UDI
Model / Reference
PPLUS120 FDA UDI

Identifiers

Catalog Number
PPLUS120 FDA UDI
Primary DI / UDI-DI
00845225003425 FDA UDI
510(k) Number
K162418 FDA UDI
FDA Product Code
ITX FDA UDI
PDU FDA UDI
GMDN Term
Intravascular ultrasound imaging catheter, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
870.1250 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Length — 120 Centimeter FDA UDI

Category: Intravascular ultrasound imaging catheter, single-use

Pioneer Plus Catheter by Philips Image Guided Therapy Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intravascular ultrasound imaging catheter, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips Image Guided Therapy Corporation

Sources (1)

  • FDA UDI dd6fc5b2-340b-4e4c-a1cb-1bfe27110f73 37 fields · synced Jun 9, 2026