Product code MCW— Cardiovascular
Auryon Atherectomy System
- Classification name
- Catheter, Peripheral, Atherectomy
- Device class
- Class 2
- Regulation
- 21 CFR 870.4875
- Advisory panel
- Cardiovascular
- Total cleared
- 146
- First cleared
- Most recent
Clearances under product code MCW — page 2
101–146 of 146- K072195 — THROMCAT THROMBECTOMY CATHETER SYSTEM
- K071350 — DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
- K061188 — SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
- K061063 — MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
- K060904 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- K060016 — THROMCAT THROMBECTOMY CATHETER SYSTEM
- K053460 — MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
- K043553 — SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300
- K041630 — ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
- K021096 — X-SIZER CATHETER SYSTEM
- K040252 — CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT
- K033997 — SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110
- K033793 — CLEANER II ROTATIONAL THROMBECTOMY SYSTEM
- K030504 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
- K024243 — REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
- K031610 — REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM
- K022640 — SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM
- K013473 — XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL
- K003570 — BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755
- K993816 — BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD
- K993564 — POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
- K993648 — ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
- K990829 — ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65
- K982363 — OASIS THROMBECTOMY CATHETER SYSTEM
- K982657 — AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100
- K973669 — THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW)
- K970233 — GELBFISH ENDO-VAC SYSTEM
- K971984 — AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200)
- K970296 — ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
- K963925 — THROMBOLYTIC BRUSH CATHETER
- K970080 — ARROW-TREROTOLA PTD CATHETER
- K960970 — POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P
- K954205 — THE AMPLATZ THROMBECTOMY DEVICE
- K960379 — ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
- K954604 — ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY
- K953997 — ROTABLATOR ROTATIONAL ANGIOPLASTY
- K942457 — GRAFT THROMBECTOMY INSTRUMENTS
- K935929 — MICROTRACK
- K933238 — ROTABLATOR, MODIFICATION
- K922970 — INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM
- K924712 — ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM
- K920707 — HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER
- K915238 — TRAC-WRIGHT TRAC 10 CATHETER
- K913450 — HEART TECHNOLOGY ROTABLATOR WIRECLIP
- K904680 — THERATEK GROUP EXCHANGE CATHETER
- K901206 — ROTABLATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.