← Back to catalogue

RotaLink™ Plus

FDA UDI

Class III (US FDA UDI)

by Boston Scientific

Identity

Trade Name
RotaLink™ Plus 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
H749236310150 FDA UDI
Description
Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device FDA UDI

Identifiers

Catalog Number
H749236310150 FDA UDI
Primary DI / UDI-DI
08714729316473 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

Category: Mechanical atherectomy system, coronary, line-powered

RotaLink™ Plus 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Boston Scientific

Sources (1)

  • FDA UDI c3923f74-2746-493e-8d28-8781e6bbb410 36 fields · synced May 30, 2026