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Cronus HP PTA Balloon Catheter

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K190037

by Nipro Medical Corporation

Identity

Trade Name
Cronus HP 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
NHP+86080 FDA UDI
Description
OTW High Pressure Peripheral Balloon Catheter FDA UDI

Identifiers

Primary DI / UDI-DI
00383790009577 FDA UDI
510(k) Number
K190037 FDA 510(k)FDA UDI
FDA Product Code
LIT FDA 510(k)FDA UDI
GMDN Term
Peripheral angioplasty balloon catheter, basic FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

No

FDA UDI

Dimensions & Sizes

Size
Balloon Diameter — 8 Millimeter FDA UDI
Balloon Length — 60 Millimeter FDA UDI
Catheter Length — 80 Centimeter FDA UDI

Cronus HP PTA Balloon Catheter by Nipro Medical Corporation — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nipro Medical Corporation

Sources (2)

  • FDA 510(k) K190037 24 fields · synced Jun 18, 2026
  • FDA UDI bd79f1f1-b73b-40ed-8aad-15a5e5301d67 36 fields · synced May 26, 2026