Zoom 7X Catheter

FDA UDI

Class II (US FDA UDI)

by Imperative Care Inc.

Identity

Trade Name: Zoom 7X Catheter FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: Zoom 7X Catheter, 137cm FDA UDI
Model / Reference: ICRC07X137 FDA UDI
Description: Zoom 7X Catheter, 137cm FDA UDI

Identifiers

Catalog Number: ICRC07X137 FDA UDI
Primary DI / UDI-DI: 00812212030757 FDA UDI
510(k) Number: K243047 FDA UDI
FDA Product Code: NRY FDA UDI
GMDN Term: Thrombectomy suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 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: Lumen/Inner Diameter — 0.071 Inch FDA UDI
Outer Diameter — 0.083 Inch FDA UDI
Catheter Length — 137 Centimeter FDA UDI

Category: Thrombectomy suction catheter

Zoom 7X Catheter by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Thrombectomy suction catheter.

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Trevo — Stryker Corp.
Penumbra System — PENUMBRA, INC. · Class II
Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Solitaire™ — Micro Therapeutics, Inc. · Class II
Stroke Fast Pack — Stryker Corp.
Indigo System — PENUMBRA, 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: Imperative Care Inc.

Sources (1)

FDA UDI b79cfcf5-3e44-4e61-ba0e-7e96af9ac998 38 fields · synced May 30, 2026