510(k) K171979 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Tubing Pack
| Applicant | Medtronic, Inc., Mounds View MN, US |
| Decision | Substantially Equivalent, Oct 27, 2017 |
| Received | Jun 30, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K171979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY8M63R4, Custom Pack HY8M63R4 Adult ECC, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB11J14R2, Custom Pack BB11J14R2 Bridge, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY7M07R6, Custom Pack HY7M07R6 E 1/4, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB7J97R8, Custom Pack CB7J97R8 U14 E Sup, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY11B40R1, Custom Pack HY11B40R1 1/4 Respirato, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB1H18R20, Custom Pack CB1H18R20 Accesory, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY8R62R13,Custom Pack HY8R62R13 E Pack, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB4W67R20, Custom Pack CB4W67R20 Adult E, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10W64R1, Custom Pack CB10W64R1 CH Access 3/8, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY10J00R12, Custom Pack HY10J00R12 ECC Small CA, Custom Perfusion System, Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10W65R1, Custom Pack CB10W65R1 CH Access1/4, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY10D90R2, Custom Pack HY10D90R2 3/8 ACC, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10R79R6, Custom Pack CB10R79R6 1/4X1/4 Loop, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10R55R5, Custom Pack CB10R55R5 3/8X3/8 Loop, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB7J98R7, Custom Pack CB7J98R7, Custom Pack CB7J98R7 3/8 Pack, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic HY10L28R3, Custom Pack HY10L28R3 1/4 Pack, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB7D76R13, Custom Pack BB7D76R13 CORR HL, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic BB9G78R8, Custom Pack BB9G78R8 ECC Supp, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
| Apr 29, 2021 | Medtronic Perfusion Systems Medtronic 1A46R11, Custom Pack 1A46R11 Neonatal, Custom Perfusion System, Sterile, Rx. Terminated |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.