510(k) K020028 ยท DQY Catheter, Percutaneous
6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
| Applicant | Boston Scientific, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jan 22, 2002 |
| Received | Jan 4, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020028
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 Guide Catheter 6F, IM Internal Mammary 90cm, .070 in (internal dia), shaft lenght, 90 cm, Catalon Number: 34356-446, UPN H749343564460, Sterile EO, Availmed S.A. de C.V. (Mexi Terminated |
DQY | None listed |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 6F, HS Hockey Stick, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-600, UPN M001196000, Sterile EO, Availmed S.A. de C.V. (Mexico), Terminated |
DQY | None listed |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 6F, MP Multipurpose 90cm, .070 in (internal dia), Shaft lenght 90cm, Catalog Number: 19-626, UPN M001196260, Sterile EO, Availmed S.A. de C.V. (Mex Terminated |
DQY | None listed |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 6F, RDC Renal double Curve, .070 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-666, UPN M001196660, Sterile EO, Availmed S.A. de C.V. (M Terminated |
DQY | None listed |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 7F, MP Multipurpose, .081 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-723, UPN M001197230, Sterile EO, Availmed S.A. de C.V. (Mexico), Terminated |
DQY | None listed |
| May 7, 2008 | Boston Scientific Corporation Boston Scientific Mach 1 peripheral Guide Catheter 8F, RDC Renal double Curve, .091 in (internal dia), Shaft lenght 55cm, Catalog Number: 19-866, UPN M001198660, Sterile EO, Availmed S.A. de C.V. (M Terminated |
DQY | None listed |
| Oct 27, 2007 | Boston Scientific Boston Scientific mach 1 Guide Catheter, VL3.5 SH Voda Left 3.5, REF 34358-78, UPN H74934358780, Sterile EO, Made in Mexico Avenida Norske Edicficio G1, Local B y H Parque Industrial La Mesa, Fracc. Terminated |
DQY | None listed |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Multipurpose Curve, UPN # H74934357380, Catalog # 34357-38. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Terminated |
DQY | None listed |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Right Curve, UPN # H74934358180, Catalog # 34358-18. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Terminated |
DQY | None listed |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091'', Amplatz Left Curve, UPN # H74934358190, Catalog # 34358-19. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Terminated |
DQY | None listed |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 7F, 0.081'', Voda Left Curve, UPN # H74934357730, Catalog # 34357-73. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tij Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.