SET Rotarex®S 6F 110cm (Straub Medical®)

FDA UDI

Class II (US FDA UDI)

by Straub Medical AG

Identity

Trade Name: SET Rotarex®S 6F 110cm (Straub Medical®) FDA UDI
Generic Name: Mechanical atherectomy system catheter/handpiece FDA UDI
Device Name: Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag. FDA UDI
Model / Reference: Version 1.0 FDA UDI
Description: Rotational Excisional Atherectomy System.The Catheter Set includes one Rotarex®S catheter (gauge 6F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag. FDA UDI

Identifiers

Catalog Number: 80236 FDA UDI
Primary DI / UDI-DI: 07640142810575 FDA UDI
510(k) Number: K172315 FDA UDI
K211738 FDA UDI
FDA Product Code: MCW FDA UDI
DQX FDA UDI
GMDN Term: Mechanical atherectomy system catheter/handpiece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4875 FDA UDI
870.1330 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Catheter Working Length — 110 Centimeter FDA UDI
Catheter Gauge — 6 French FDA UDI

SET Rotarex®S 6F 110cm (Straub Medical®) by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K172315 also covers:

K211738 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Straub Medical AG

Sources (1)

FDA UDI 9a081a15-c8a1-4a19-b80e-1ff217f60992 38 fields · synced Jun 6, 2026