Control RX-LP Mechanical Thrombectomy System

FDA UDI

Class II (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name: Control RX-LP Mechanical Thrombectomy System FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. FDA UDI
Model / Reference: ASP-1001 FDA UDI
Description: The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. FDA UDI

Identifiers

Catalog Number: ASP-1001 FDA UDI
Primary DI / UDI-DI: B090ASP10010 FDA UDI
510(k) Number: K131998 FDA UDI
FDA Product Code: QEZ FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 6 French FDA UDI
Catheter Length — 136 Centimeter FDA UDI

Category: General-purpose syringe, single-use Thrombectomy suction catheter

Control RX-LP Mechanical Thrombectomy System by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Thrombectomy suction catheter.

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Pounce ™ Thrombectomy — Surmodics, Inc. · Class II

Cleared under the same submission

K131998 also covers:

Control RX-LP Mechanical Thrombectomy System, 136cm — ZIEN Medical Technologies, LLC

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: ZIEN Medical Technologies, LLC

Sources (1)

FDA UDI 5ea14b29-465c-4000-893b-9cd0e2df093f 36 fields · synced May 30, 2026