Control 10T Mechanical Thrombectomy Filter

FDA UDI

Class II (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name: Control 10T Mechanical Thrombectomy Filter FDA UDI
Generic Name: Thrombectomy tubing set, non-electronic FDA UDI
Device Name: The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.” FDA UDI
Model / Reference: ASP-1039 FDA UDI
Description: The Control 10T Mechanical Thrombectomy Filter is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy Filter is a “tool,” not a “treatment.” FDA UDI

Identifiers

Catalog Number: ASP-1039 FDA UDI
Primary DI / UDI-DI: B090ASP10390 FDA UDI
FDA Product Code: BYY FDA UDI
GMDN Term: Thrombectomy tubing set, non-electronic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6740 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Thrombectomy tubing set, non-electronic

Control 10T Mechanical Thrombectomy Filter by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy tubing set, non-electronic.

Control 10T Mechanical Thrombectomy System Tubing, Female Suction — ZIEN Medical Technologies, LLC · Class II
Control 10T Mechanical Thrombectomy System Tubing, Female Suction — ZIEN Medical Technologies, LLC · Class II
Control 10T Mechanical Thrombectomy System Tubing — ZIEN Medical Technologies, LLC · Class II
Control 10T Mechanical Thrombectomy System Tubing, 3-Pack — ZIEN Medical Technologies, LLC · Class II
Control 10T Mechanical Thrombectomy Filter — ZIEN Medical Technologies, LLC · 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

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

Manufacturer

Manufacturer: ZIEN Medical Technologies, LLC

Sources (1)

FDA UDI 6ed1cb3f-b6eb-4f3c-b456-c82ee44dee47 34 fields · synced Jun 6, 2026