510(k) K032884
- Device
- FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH
- Applicant
- BOSTON SCIENTIFIC EPI
- 510(k) number
- K032884
- Product code
- NFA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-08-06
- Date received
- 2003-09-16
- Regulation
- 870.1250
- Classification name
- Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBBIE MCINTIRE
- Address
- 2525 Walsh Ave. Santa Clara CA US 95051 95051
FDA Registration Numbers#
- 3004859241
- 3007738736
- 2124215
- 3007695959
- 2183870
- 2183744
- 3002807314
Source Documents#
Other 510(k) Records For Product Code NFA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073523 | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | Medtronic, Inc. | 2008-08-01 |
| K073563 | MODIFICATION TO PROXIS SYSTEM | St Jude Medical | 2008-01-31 |
| K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2007-01-19 |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Kensey Nash Corp. | 2006-10-20 |
| K060651 | PROXIS SYSTEM, MODEL EPS101 | St Jude Medical | 2006-09-13 |
| K052523 | PROXIS SYSTEM | Velocimed, Inc. | 2006-09-07 |
| K062201 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-08-11 |
| K061332 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | Boston Scientific Corp | 2006-08-11 |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Kensey Nash Corp. | 2006-07-11 |
| K053195 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-06-23 |
| K051984 | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 | Boston Scientific Corp | 2006-04-10 |
| K052280 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | Boston Scientific Corp | 2005-11-07 |
| K051179 | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | Boston Scientific Corp | 2005-06-08 |
| K042040 | TRIACTIV SYSTEM | Kensey Nash Corp. | 2005-03-23 |
| K023691 | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | Boston Scientific Epi | 2003-06-04 |
Legacy Summary#
summary
FDA Review#
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