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Stealth

FDA UDI

Class II (US FDA UDI)

by Cardiovascular Systems, Inc.

Identity

Trade Name
Stealth FDA UDI
Generic Name
Mechanical atherectomy system catheter, peripheral FDA UDI
Device Name
STEALTH PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT FDA UDI
Model / Reference
PRD-SC30-MICRO FDA UDI
Description
STEALTH PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT FDA UDI

Identifiers

Catalog Number
7-10059-01 FDA UDI
Primary DI / UDI-DI
10850000491264 FDA UDI
FDA Product Code
MCW FDA UDI
GMDN Term
Mechanical atherectomy system catheter, peripheral FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4875 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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Mechanical atherectomy system catheter, peripheral

Stealth by Cardiovascular Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system catheter, peripheral.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardiovascular Systems, Inc.

Sources (1)

  • FDA UDI 919bbb70-5500-4235-871f-89ea589c40d5 36 fields · synced May 30, 2026