Identity
- Trade Name
- FlexCath Advance™ FDA UDI
- Generic Name
- Haemostasis valve FDA UDI
- Device Name
- SHEATH 4FC12 FLEXCATH ADVANCE 12F US FDA UDI
- Model / Reference
- 4FC12 FDA UDI
- Description
- SHEATH 4FC12 FLEXCATH ADVANCE 12F US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000043773 FDA UDI
- 510(k) Number
- K123591 FDA UDI
- FDA Product Code
- DRA FDA UDI
- GMDN Term
- Haemostasis valve FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1280 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 65.0 Centimeter FDA UDI
Category: Haemostasis valve
FlexCath Advance™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemostasis valve.
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Cleared under the same submission
K123591 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
- Medtronic, Inc.
Sources (1)
- FDA UDI ee8660b2-85dc-4f0f-9129-8df03fdee442 37 fields · synced May 30, 2026