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Diamondback Coronary

FDA UDI

Class III (US FDA UDI)

by Cardiovascular Systems, Inc.

Identity

Trade Name
Diamondback Coronary FDA UDI
Generic Name
Mechanical atherectomy system, coronary, line-powered FDA UDI
Device Name
DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown FDA UDI
Model / Reference
DBEC-125M FDA UDI
Description
DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown FDA UDI

Identifiers

Catalog Number
7-10000-01 FDA UDI
Primary DI / UDI-DI
10852528005336 FDA UDI
FDA Product Code
MCX FDA UDI
GMDN Term
Mechanical atherectomy system, coronary, line-powered FDA UDI

Classification

Device Class
Class III 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, coronary, line-powered

Diamondback Coronary by Cardiovascular Systems, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system, coronary, line-powered.

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 435ad1bf-3273-4423-b903-6f9b3ee6daa4 35 fields · synced May 30, 2026