FreedomFlow Orbital Circumferential Atherectomy System
FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 3-Sphere
3manufacturers in China registered for this device type
3catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Quasar Electronics Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Dongguan King Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
Record
| Listed by | Cardio Flow, Inc., United States |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K231538 |
| Record published | 2024-06-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 35 °C; Storage environment temperature 15 to 35 °C; Handling environment humidity 10 to 85 % RH; Storage environment humidity 30 to 50 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Case of 5 |
| Sizes | Atherectomy rotating component diameter 1.5 to 2 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H6004 | Atherectomy Rotating Component Diameter 1.5 mm | In distribution |
| H6001 | Atherectomy Rotating Component Diameter 1.5 mm | In distribution |
| H6002 | Atherectomy Rotating Component Diameter 2.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diamondback Peripheral | Cardiovascular Systems Incorporated | 44 |
| Turbo-Elite™ | Spectranetics Corp. | 24 |
| Stealth | Cardiovascular Systems Incorporated | 20 |
| Zilient | Cardiovascular Systems Incorporated | 16 |
| TurboHawk | Covidien LP | 15 |
| HawkOne | Covidien LP | 14 |
| Turbo-Elite Laser Atherectomy Catheter | Spectranetics Corp. | 12 |
| SilverHawk | Covidien LP | 11 |
| Auryon Atherectomy Catheter | Eximo Medical Ltd | 10 |
| Revolution Peripheral Atherectomy System | Rex Medical | 8 |
| Peripheral RotaLink® Plus | Boston Scientific Corporation | 8 |
| SilverHawkTM | Covidien LP | 8 |
Showing 12 of 102. All products under Catheter, Peripheral, Atherectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250723 | 2025-04-25 |
| K242947 | 2024-11-05 |
| K233483 | 2024-02-15 |
| K231538 | 2023-09-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.