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Rotapro™

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
ROTAPRO™ FDA UDI
Generic Name
Mechanical atherectomy system, coronary, line-powered FDA UDI
Device Name
Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device FDA UDI
Model / Reference
H749394672000 FDA UDI
Description
Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device FDA UDI

Identifiers

Catalog Number
H749394672000 FDA UDI
Primary DI / UDI-DI
08714729999591 FDA UDI
PMA Number
P900056 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

Dimensions & Sizes

Size
Guidewire Diameter — 2.00 Millimeter FDA UDI

Category: Mechanical atherectomy system, coronary, line-powered

Rotapro™ by Boston Scientific — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

P900056 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI b1036072-bb75-4fff-9441-d1bea2700c6c 36 fields · synced May 30, 2026