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ZOOM™ Reperfusion Catheter

FDA UDI

Class II (US FDA UDI)

by Imperative Care Inc.

Identity

Trade Name
ZOOM™ Reperfusion Catheter FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Device Name
ZOOM 035 160 cm RC FDA UDI
Model / Reference
ICRC035158 FDA UDI
Description
ZOOM 035 160 cm RC FDA UDI

Identifiers

Catalog Number
ICRC035158 FDA UDI
Primary DI / UDI-DI
00812212030207 FDA UDI
510(k) Number
K202182 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

Dimensions & Sizes

Size
Catheter Length — 160 Centimeter FDA UDI
Outer Diameter — 0.051 Inch FDA UDI
Lumen/Inner Diameter — 0.035 Inch FDA UDI

Category: Thrombectomy suction catheter

ZOOM™ Reperfusion 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.

Cleared under the same submission

K202182 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Imperative Care Inc.

Sources (1)

  • FDA UDI e91f794f-e3e6-429e-a7cc-fa68c8983746 38 fields · synced Jun 8, 2026