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FreedomFlow Orbital Circumferential Atherectomy System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- FreedomFlow Orbital Circumferential Atherectomy System FDA UDI
- Generic Name
- Mechanical atherectomy system catheter, peripheral FDA UDI
- Device Name
- FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere FDA UDI
- Model / Reference
- H6002 FDA UDI
- Description
- FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-sphere FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850040691054 FDA UDI
- 510(k) Number
- K231538 FDA UDI
- FDA Product Code
- MCW FDA UDI
- GMDN Term
- Mechanical atherectomy system catheter, peripheral FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4875 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
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Atherectomy Rotating Component Diameter — 2.0 Millimeter FDA UDI
Category: Mechanical atherectomy system catheter, peripheral
FreedomFlow Orbital Circumferential Atherectomy System by Cardio Flow Inc., — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mechanical atherectomy system catheter, peripheral.
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- SilverHawk — Covidien LP · Class II
- HawkOne™ — Covidien LP · Class II
- SilverHawkTM — Covidien LP · Class II
Cleared under the same submission
K231538 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
- Cardio Flow Inc.,
Sources (1)
- FDA UDI 8305fe05-9612-44d5-8146-a5c1698aaa71 37 fields · synced May 30, 2026