Zoom RDL Radial Access System, 95cm

FDA UDI

Class II (US FDA UDI)

by Imperative Care Inc.

Identity

Trade Name: Zoom RDL Radial Access System, 95cm FDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: Zoom RDL, 95cm with dilator FDA UDI
Model / Reference: ICTC088095R FDA UDI
Description: Zoom RDL, 95cm with dilator FDA UDI

Identifiers

Catalog Number: ICTC088095R FDA UDI
Primary DI / UDI-DI: 00812212030511 FDA UDI
510(k) Number: K220807 FDA UDI
FDA Product Code: DQY FDA UDI
QJP FDA UDI
GMDN Term: Vascular guide-catheter, single-use 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 — 0.088 Inch FDA UDI
Outer Diameter — 0.110 Inch FDA UDI
Catheter Length — 95 Centimeter FDA UDI

Category: Vascular guide-catheter, single-use Vascular microcatheter

Zoom RDL Radial Access System, 95cm by Imperative Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular microcatheter.

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Merit Maestro® — Merit Medical Systems, Inc. · Class II
Lantern Delivery Catheter — PENUMBRA, INC. · Class II
Direxion™ Fathom™-16 System — Boston Scientific · Class II

Cleared under the same submission

K220807 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 ac3e5484-7246-41e1-828a-addcd24ee950 38 fields · synced May 30, 2026