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Cronus™ HP - OTW PTA BALLOON CATHETER

FDA UDI

Class II (US FDA UDI)

by Nipro Medical Corporation

Identity

Trade Name
Cronus™ HP - OTW PTA BALLOON CATHETER FDA UDI
Generic Name
Peripheral angioplasty balloon catheter, basic FDA UDI
Device Name
OTW High Pressure Peripheral Balloon Catheter FDA UDI
Model / Reference
NCH+106080 FDA UDI
Description
OTW High Pressure Peripheral Balloon Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00383790003506 FDA UDI
510(k) Number
K151141 FDA UDI
FDA Product Code
LIT FDA UDI
GMDN Term
Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1250 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

Cronus™ HP - OTW PTA BALLOON CATHETER by Nipro Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151141 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (1)

  • FDA UDI a5c228b7-6ac5-429d-ac58-80b9cc2c1d96 37 fields · synced Jun 1, 2026