FDA Product Code
FDA Product Code NFA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1250
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K073523 | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | Medtronic, Inc. | 2008-08-01 | Traditional | PDF ↗ |
| K073563 | MODIFICATION TO PROXIS SYSTEM | St Jude Medical | 2008-01-31 | Special | PDF ↗ |
| K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2007-01-19 | Special | PDF ↗ |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Kensey Nash Corp. | 2006-10-20 | Special | PDF ↗ |
| K060651 | PROXIS SYSTEM, MODEL EPS101 | St Jude Medical | 2006-09-13 | Traditional | PDF ↗ |
| K052523 | PROXIS SYSTEM | Velocimed, Inc. | 2006-09-07 | Traditional | PDF ↗ |
| K061332 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | Boston Scientific Corp | 2006-08-11 | Special | PDF ↗ |
| K062201 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-08-11 | Special | PDF ↗ |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Kensey Nash Corp. | 2006-07-11 | Traditional | PDF ↗ |
| K053195 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-06-23 | Traditional | PDF ↗ |
| K051984 | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 | Boston Scientific Corp | 2006-04-10 | Traditional | PDF ↗ |
| K052280 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | Boston Scientific Corp | 2005-11-07 | Traditional | PDF ↗ |
| K051179 | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | Boston Scientific Corp | 2005-06-08 | Special | PDF ↗ |
| K042040 | TRIACTIV SYSTEM | Kensey Nash Corp. | 2005-03-23 | Traditional | PDF ↗ |
| K032884 | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH | Boston Scientific Epi | 2004-08-06 | Traditional | PDF ↗ |
| K023691 | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | Boston Scientific Epi | 2003-06-04 | Traditional | PDF ↗ |
| K030201 | MODIFICATION TO EXPORT ASPIRATION CATHETER | Medtronic Vascular | 2003-03-26 | Special | PDF ↗ |
| K023878 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Vascular | 2003-01-24 | Special | PDF ↗ |
| K013913 | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Percusurge, Inc. | 2002-11-15 | Traditional | PDF ↗ |
| K023303 | EXPORT ASPIRATION CATHETER | Medtronic Vascular | 2002-10-29 | Special | PDF ↗ |
| K014223 | MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM | Medtronic Percusurge, Inc. | 2002-01-25 | Special | PDF ↗ |
| K003992 | PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Percu Surge, Inc. | 2001-06-01 | Traditional | PDF ↗ |
Product code NFA · Class II · Cardiovascular. Data: openFDA.