510(k) K063313 ยท NTE Temporary Carotid Catheter For Embolic Capture
FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)
| Applicant | Boston Scientific Corp, Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 5, 2006 |
| Received | Nov 2, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063313
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, US, Material H749201001900, Catalog # 20100-190, Sterilized with irradiation, Made in USA: 2011 Stierlin Co Terminated |
NTE | None listed |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, US, Material H749201003000, Catalog # 20100-300, Sterilized with irradiation, Made in USA: 2011 Stierlin Cour Terminated |
NTE | None listed |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, OUS CV, Material H749201003990, Catalog # 20100-399, Sterilized with irradiation, Made in USA: 2011 Stierlin Terminated |
NTE | None listed |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, OUS CV, Material H749201004000, Catalog # 20100-400, Sterilized with irradiation, Made in USA: 2011 Stierlin Terminated |
NTE | None listed |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 190cm, 3.5-5.5 mm, MT OUS PV, Material H749201051900, Catalog # 20105-190, Sterilized with irradiation, Made in USA: 2011 Stierl Terminated |
NTE | None listed |
| Oct 14, 2008 | Boston Scientific Corporation Boston Scientific FilterWire EZ" Embolic Protection System, Model FW EZ 300cm, 3.5-5.5 mm, MT OUS PV, Material H749201053000, Model # 20105-300, Sterilized with irradiation, Made in USA: 2011 Stierlin Terminated |
NTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.