Footswitch (Straub Medical®)
The footswitch is a pedal that allows the physician to turn the Motor on and off by pressing down the switch, if the physician prefers to operate the system in this way. The footswitch is a…
The footswitch is a pedal that allows the physician to turn the Motor on and off by pressing down the switch, if the physician prefers to operate the system in this way. The footswitch is a part of Straub Medical Drive System.
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 | Straub Medical AG, Switzerland |
|---|---|
| FDA product code | MCW |
| Device type | Catheter, Peripheral, Atherectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4875 |
| Establishment | Manufacturer |
| 510(k) | K172315 |
| Record published | 2020-01-31 |
| Record revised | 2025-09-22 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2025-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Version 1.0 | Withdrawn |
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 |
|---|---|
| K172315 | 2018-04-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Bard Peripheral Vascular, Inc. | 510(k) number | 2025-02-05 | Class I | Under Investigation by firm | Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, whic | 15,755 |
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.