← Back to catalogue

Chaperon Guiding Catheter

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K082385

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
GC595M1ST FDA UDI
Description
Guides FDA UDI

Identifiers

Catalog Number
GC595M1ST FDA UDI
Primary DI / UDI-DI
00810170012846 FDA UDI
510(k) Number
K082385 FDA 510(k)FDA UDI
FDA Product Code
DQY FDA 510(k)FDA UDI
GMDN Term
Vascular guide-catheter, single-use FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)FDA UDI
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Chaperon Guiding Catheter by Microvention Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Microvention Inc.
FDA Applicant
MicroVention, Inc.

Sources (2)

  • FDA 510(k) K082385 24 fields · synced Jun 19, 2026
  • FDA UDI 7a823b75-a82f-4763-9ebc-3ea855dcfc2c 37 fields · synced May 27, 2026