FDA Product Code
FDA Product Code MCW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.4875
510(k) Clearances — 146 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K072195 | THROMCAT THROMBECTOMY CATHETER SYSTEM | Kensey Nash Corp. | 2007-08-23 | Special | PDF ↗ |
| K071350 | DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM | Cardiovascular Systems, Inc. | 2007-08-22 | Traditional | PDF ↗ |
| K061188 | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM | Foxhollow Technologies, Inc. | 2006-10-23 | Traditional | PDF ↗ |
| K061063 | MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300 | Foxhollow Technologies, Inc. | 2006-05-18 | Special | PDF ↗ |
| K060904 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM | Rex Medical, L.P. | 2006-04-28 | Special | PDF ↗ |
| K060016 | THROMCAT THROMBECTOMY CATHETER SYSTEM | Kensey Nash Corp. | 2006-04-25 | Traditional | PDF ↗ |
| K053460 | MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, | Fox Hollow Technologies | 2006-01-13 | Special | PDF ↗ |
| K043553 | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 | Fox Hollow Technologies | 2005-02-18 | Special | PDF ↗ |
| K041630 | ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS | Cardiovascular Systems Incorporated | 2005-01-31 | Abbreviated | PDF ↗ |
| K021096 | X-SIZER CATHETER SYSTEM | Ev3 Corporation | 2004-09-08 | Traditional | PDF ↗ |
| K040252 | CLEANER ROTATIONAL THROMBECTOMY SYSTEM KIT | Rex Medical | 2004-02-26 | Special | PDF ↗ |
| K033997 | SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 | Bacchus Vascular, Inc. | 2004-02-04 | Special | PDF ↗ |
| K033793 | CLEANER II ROTATIONAL THROMBECTOMY SYSTEM | Rex Medical | 2003-12-16 | Traditional | PDF ↗ |
| K030504 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 | Idev Technologies, Inc. | 2003-09-16 | Traditional | PDF ↗ |
| K024243 | REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 | Fox Hollow Technologies | 2003-06-20 | Traditional | PDF ↗ |
| K031610 | REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM | Rex Medical | 2003-05-27 | Traditional | PDF ↗ |
| K022640 | SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM | Bacchus Vascular, Inc. | 2002-12-02 | Special | PDF ↗ |
| K013473 | XTD THROMBECTOMY CATHETER, XX CM, MODEL# CT000500X; XTD CONTROL CONSOLE, MODEL # CT0006001; XTD COLLECTION BOTTLE, MODEL | Xtrak Medical, Inc. | 2002-03-06 | Traditional | PDF ↗ |
| K003570 | BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 | Bacchus Vascular, Inc. | 2001-06-06 | Traditional | PDF ↗ |
| K993816 | BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FD | Baxter Edwards | 2000-05-04 | Traditional | PDF ↗ |
| K993564 | POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002 | Possis Medical, Inc. | 2000-04-28 | Traditional | PDF ↗ |
| K993648 | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER | Boston Scientific Corporation Northwest Technology | 1999-11-24 | Special | PDF ↗ |
| K990829 | ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509 (CATHETER KIT WITH INTRODUCER SHEATHS),PT-65 | Arrow Intl., Inc. | 1999-05-04 | Special | PDF ↗ |
| K982363 | OASIS THROMBECTOMY CATHETER SYSTEM | Boston Scientific Corp | 1999-02-23 | Traditional | PDF ↗ |
| K982657 | AMPLATZ THROMBECTOMY DEVICE MODELS ATD 601, ATD 602, ATD 801, ATD 802, FOOT PEDAL ASSEMBLY MODEL AK 100 | Microvena Corp. | 1998-11-18 | Traditional | PDF ↗ |
| K973669 | THROMBOLYTIC BRUSH CATHETER, OVER THE WIRE (OTW) | Micro Therapeutics, Inc. | 1998-02-06 | Traditional | PDF ↗ |
| K970233 | GELBFISH ENDO-VAC SYSTEM | Gary A. Gelbfish | 1997-10-08 | Traditional | PDF ↗ |
| K971984 | AMPLATZ THROMBECTOMY DEVICE(ATD 603,602,801,802)/FOOT PEDAL ASSEMBLY(AK 200) | Microvena Corp. | 1997-09-19 | Traditional | PDF ↗ |
| K970296 | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER | Boston Scientific Corp | 1997-08-29 | Traditional | PDF ↗ |
| K963925 | THROMBOLYTIC BRUSH CATHETER | Micro Therapeutics, Inc. | 1997-08-08 | Traditional | PDF ↗ |
| K970080 | ARROW-TREROTOLA PTD CATHETER | Arrow Intl., Inc. | 1997-07-25 | Traditional | PDF ↗ |
| K960970 | POSSIS ANGIOJET RAPID THROMBECTOMY CATHETER SYSTEM, F105 CATHETER,MODEL 3030C,LF140 CATHETER,MODEL 3040C,PUMP SET 3020P | Possis Medical, Inc. | 1996-12-03 | Traditional | PDF ↗ |
| K954205 | THE AMPLATZ THROMBECTOMY DEVICE | Microvena Corp. | 1996-08-13 | Traditional | PDF ↗ |
| K960379 | ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE | Heart Technology Mfg., Inc. | 1996-04-25 | Traditional | PDF ↗ |
| K954604 | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE; HTI FLOPPY | Heart Technology Mfg., Inc. | 1996-01-18 | Traditional | PDF ↗ |
| K953997 | ROTABLATOR ROTATIONAL ANGIOPLASTY | Heart Technology Mfg., Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K942457 | GRAFT THROMBECTOMY INSTRUMENTS | Intramed Laboratories, Inc. | 1995-02-07 | Traditional | PDF ↗ |
| K935929 | MICROTRACK | Devices For Vascular Intervention, Inc. | 1994-03-10 | Traditional | PDF ↗ |
| K933238 | ROTABLATOR, MODIFICATION | Heart Technology, Inc. | 1993-08-24 | Traditional | PDF ↗ |
| K922970 | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM | Intensive Technology, Inc. | 1993-01-13 | Traditional | PDF ↗ |
| K924712 | ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM | Hearing Tech, Inc. | 1992-12-08 | Traditional | PDF ↗ |
| K920707 | HOLLOW MOTOR DRIVE UNIT W/ TORQUE CONTROLLER | Devices For Vascular Intervention, Inc. | 1992-11-23 | Traditional | PDF ↗ |
| K915238 | TRAC-WRIGHT TRAC 10 CATHETER | Dow Corning Wright | 1992-02-19 | Traditional | PDF ↗ |
| K913450 | HEART TECHNOLOGY ROTABLATOR WIRECLIP | Heart Technology, Inc. | 1991-09-06 | Traditional | PDF ↗ |
| K904680 | THERATEK GROUP EXCHANGE CATHETER | Dow Corning Wright | 1990-12-27 | Traditional | PDF ↗ |
| K901206 | ROTABLATOR | Heart Technology, Inc. | 1990-09-14 | Traditional | PDF ↗ |
Product code MCW · Class II · Cardiovascular. Data: openFDA.