510(k) K010874 ยท DQY Catheter, Percutaneous
6F MACH 1, MODEL 34356-XXX
| Applicant | Boston Scientific Corp, Maple Grove MN, US |
| Decision | Substantially Equivalent, Jun 21, 2001 |
| Received | Mar 23, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010874
| 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 |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Internal Mammary Curve, UPN # H74934356260, Catalog # 34356-26. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Me Terminated |
DQY | None listed |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F, 0.070'', Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tij Terminated |
DQY | None listed |
| Feb 7, 2007 | Boston Scientific Boston Scientific Mach 1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN # M001196620, Catalog # 19-662. Made in Mexico: Edificio G1 Local B, H, Parque Industrial La Mesa, Tijuana, Baja Cal Terminated |
DQY | None listed |
| Jan 24, 2006 | Boston Scientific Scimed Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Sci Terminated |
DQY | None listed |
| Jan 24, 2006 | Boston Scientific Scimed Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Sc Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.