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SET Aspirex™ S 6F 135cm

FDA UDI

Class II (US FDA UDI)

by Straub Medical AG

Identity

Trade Name
SET Aspirex™ S 6F 135cm FDA UDI
Generic Name
Thrombectomy rotational catheter FDA UDI
Device Name
The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 6F; length 135cm), one Aspirex™ Guidewire (0.018” diameter; 320 cm in length), one collecting bag, and one sterile drape. FDA UDI
Model / Reference
80325 FDA UDI
Description
The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 6F; length 135cm), one Aspirex™ Guidewire (0.018” diameter; 320 cm in length), one collecting bag, and one sterile drape. FDA UDI

Identifiers

Catalog Number
80325 FDA UDI
Primary DI / UDI-DI
07640142811329 FDA UDI
510(k) Number
K220270 FDA UDI
K230356 FDA UDI
FDA Product Code
QEW FDA UDI
DQX FDA UDI
GMDN Term
Thrombectomy rotational catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5150 FDA UDI
870.1330 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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6 French FDA UDI
Catheter Working Length — 135 Centimeter FDA UDI

Category: Thrombectomy rotational catheter

SET Aspirex™ S 6F 135cm by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy rotational catheter.

Cleared under the same submission

K220270 also covers:

K230356 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Straub Medical AG

Sources (1)

  • FDA UDI 7874da76-9840-4f5b-802a-9d982c1d6aae 37 fields · synced May 30, 2026