Zoom 6F Insert Catheter, VTK

FDA UDI

Class II (US FDA UDI)

by Imperative Care Inc.

Identity

Trade Name: Zoom 6F Insert Catheter, VTK FDA UDI
Generic Name: Angiographic catheter, single-use FDA UDI
Device Name: Zoom 6F Insert Catheter, VTK, 140cm FDA UDI
Model / Reference: IC6FVTK140 FDA UDI
Description: Zoom 6F Insert Catheter, VTK, 140cm FDA UDI

Identifiers

Catalog Number: IC6FVTK140 FDA UDI
Primary DI / UDI-DI: 00812212030603 FDA UDI
510(k) Number: K233975 FDA UDI
FDA Product Code: DQO FDA UDI
GMDN Term: Angiographic catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1200 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 Length — 140 Centimeter FDA UDI
Outer Diameter — 0.082 Inch FDA UDI
Lumen/Inner Diameter — 0.041 Inch FDA UDI

Category: Angiographic catheter, single-use

Zoom 6F Insert Catheter, VTK by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiographic catheter, single-use.

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Performa® — Merit Medical Systems, Inc. · Class II
ConcierGE Guiding Excellence™ — Merit Medical Systems, Inc. · Class II
INFINITI — Cordis US Corp. · Class II
CXI — COOK INCORPORATED · Class II

Cleared under the same submission

K233975 also covers:

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 41c78406-24e5-449e-a1a8-2f7af6c722fc 38 fields · synced May 30, 2026