Identity
- Trade Name
- Chaperon Guiding Catheter FDA UDI
- Generic Name
- Vascular guide-catheter, single-use FDA UDI
- Device Name
- Guides FDA UDI
- Model / Reference
- GC695STVT FDA UDI
- Description
- Guides FDA UDI
Identifiers
- Catalog Number
- GC695STVT FDA UDI
- Primary DI / UDI-DI
- 00810170012402 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
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
MR Conditional FDA UDI
Category: Vascular guide-catheter, single-use
Chaperon Guiding Catheter by Microvention Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular guide-catheter, single-use.
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- 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
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Cleared under the same submission
K082385 also covers:
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
- Chaperon Guiding Catheter — MICROVENTION INC.
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 b0f9ea08-ee05-411c-9990-f7d5f253115d 37 fields · synced May 29, 2026