Carrier™ Delivery Catheter

FDA UDI

Class II (US FDA UDI)

by Balt Usa Llc

Identity

Trade Name: Carrier™ Delivery Catheter FDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier™ Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier™ Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier™ Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only. FDA UDI
Model / Reference: CR7071162 FDA UDI
Description: The Carrier™ Delivery Catheter is a single lumen, variable stiffness, composite catheter. The design facilitates the advancement of the catheter and is intended to assist the delivery of interventional devices in the peripheral and neurovasculature. The outer surface of the Carrier™ Delivery Catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of the Carrier™ Delivery Catheter incorporates a luer fitting for the attachment of accessories. Two radiopaque markers at the distal end help to facilitate fluoroscopic visualization. A Steam Shaping Mandrel and Peel-away Introducer Tube are included within the tray. The Carrier™ Delivery Catheter is provided sterile, non-pyrogenic, and is intended for single use only. FDA UDI

Identifiers

Catalog Number: N/A FDA UDI
Primary DI / UDI-DI: 00840303713487 FDA UDI
510(k) Number: K230609 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

Yes

FDA UDI

Dimensions & Sizes

Size: Catheter Length — 162 Centimeter FDA UDI

Category: Vascular guide-catheter, single-use

Carrier™ Delivery Catheter by Balt Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vascular guide-catheter, single-use.

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Zebra — QApel Medical, Inc. · Class II
Mach1™ — Boston Scientific · Class II
SHERPA NX BALANCED — MEDTRONIC, INC. · Class II

Cleared under the same submission

K230609 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: Balt Usa Llc

Sources (1)

FDA UDI fe5a1e91-5299-44f4-88e9-c043343218eb 38 fields · synced May 30, 2026