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Prodigy™ Catheter

FDA UDI

Class II (US FDA UDI)

by Imperative Care Inc.

Identity

Trade Name
Prodigy™ Catheter FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Device Name
6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 mm) FDA UDI
Model / Reference
PRODIGY6F FDA UDI
Description
6F Prodigy™ Catheter Length: 137 cm Inner Diameter: 0.071 in Outer Diameter: 0.085 in (2.13 mm) FDA UDI

Identifiers

Catalog Number
PRODIGY6F FDA UDI
Primary DI / UDI-DI
08500320790053 FDA UDI
510(k) Number
K214114 FDA UDI
FDA Product Code
QEW FDA UDI
GMDN Term
Thrombectomy suction catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5150 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Dimensions & Sizes

Size
Catheter Length — 137 Centimeter FDA UDI
Catheter Inner Diameter — 0.071 Inch FDA UDI
Outer Diameter — 0.085 Inch FDA UDI

Prodigy™ Catheter by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K214114 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imperative Care Inc.

Sources (1)

  • FDA UDI eb506e26-0aee-48c5-899f-701166b63e87 39 fields · synced Jun 8, 2026