510(k) K981613 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
COBE SMARXT TUBING AND CONNECTORS
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Oct 26, 1998 |
| Received | May 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2019 | LivaNova USA Inc. LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs includ Terminated |
DWE | None listed |
| Dec 19, 2017 | LivaNova USA Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | None listed |
| Jun 29, 2017 | Sorin Group USA, Inc. NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.