510(k) K061009 ยท EZN Dilator, Catheter, Ureteral
PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS
| Applicant | Onset Medical Corporation, Mission Viejo CA, US |
| Decision | Substantially Equivalent, May 2, 2006 |
| Received | Apr 12, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M0062551020, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 13/16/36, Ureteral dilator, Catalog Number: 255104; Product Number: M0062551040, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator, Catalog Number: 255105; Product Number: M0062551050, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 12/15/28, Ureteral dilator, Catalog Number: 255106; Product Number: M0062551060, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
| Apr 30, 2008 | Boston Scientific Corporation Pathway Balloon Expandable Ureteral Access Sheath- 12/15/46, Ureteral dilator, Catalog Number: 255108; Product Number: M0062551080, Onset Medical, Boston Scientific Corp., Natick, MA 01760 Terminated |
EZN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.