Export Advance™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Export Advance™ FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: CATH ADVANCE ASPIR EXPORT ADVANCE NSR FDA UDI
Model / Reference: ADVANCE FDA UDI
Description: CATH ADVANCE ASPIR EXPORT ADVANCE NSR FDA UDI

Identifiers

Primary DI / UDI-DI: 00643169647343 FDA UDI
510(k) Number: K152335 FDA UDI
FDA Product Code: KRA FDA UDI
QEZ FDA UDI
GMDN Term: Thrombectomy suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 FDA UDI
870.5150 FDA UDI
Commercial Distribution: 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 140.0 Centimeter FDA UDI
Lumen/Inner Diameter — 1.78 Millimeter FDA UDI
Catheter Gauge — 6.0 French FDA UDI

Category: Thrombectomy suction catheter

Export Advance™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Penumbra System — PENUMBRA, INC. · Class II
Trevo — Stryker Corp.
Penumbra System — PENUMBRA, INC. · Class II
Pounce ™ Thrombectomy — Surmodics, Inc. · Class II

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: Medtronic, Inc.

Sources (1)

FDA UDI fbc35385-853d-4a6c-b5b9-73b9dfc17dd5 37 fields · synced May 30, 2026