Chaperon Guiding Catheter

FDA UDI

Class II (US FDA UDI)

by Microvention Inc.

Identity

Trade Name: Chaperon Guiding Catheter FDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: Guides FDA UDI
Model / Reference: GC595STJB FDA UDI
Description: Guides FDA UDI

Identifiers

Catalog Number: GC595STJB FDA UDI
Primary DI / UDI-DI: 00810170012303 FDA UDI
510(k) Number: K082385 FDA UDI
FDA Product Code: DQY 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

MRI Safety

MR Conditional FDA UDI

Category: Vascular guide-catheter, single-use

The Chaperon Guiding Catheter is a flexible, single-use vascular guide-catheter designed for the percutaneous transluminal passage and placement of diagnostic or interventional catheters, leading leads (e.g., pacing leads, balloon dilatation catheters), needles or guidewires through its lumens within the vascular system. This device may be rigid or flexible, non-steerable or steerable, single- or multiple-lumen devices with preformed shapes such as straight or hockey stick configurations. The Chaperon Guiding Catheter is intended for one-time use and does not include a transseptal needle. Its single-use nature makes it less suitable for implantation.

Similar devices

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

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

Cleared under the same submission

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: Microvention Inc.

Sources (1)

FDA UDI 6ee87ba4-0e11-4cad-950b-2847eaa254d9 37 fields · synced Jul 22, 2026