COBE SMARXT TUBING AND CONNECTORS— 510(k) K981613
Substantially EquivalentCobe Cardiovascular, Inc.
FDA 510(k) clearance K981613 for COBE SMARXT TUBING AND CONNECTORS, Substantially Equivalent on 1998-10-26. Applicant: Cobe Cardiovascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Cobe Cardiovascular, Inc.
- Product code
- Code DWE
- Device class
- Class 2
- Regulation
- 21 CFR 870.4390
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arvada, CO, US
Recent devices under product code DWE
view allMore clearances from Cobe Cardiovascular, Inc.
view all- K050111 — SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG
- K042473 — COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
- K040184 — DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
- K033641 — SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
- K030462 — COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
Adverse events under product code DWE
product code DWE- Death
- 9
- Malfunction
- 754
- Total
- 763
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K981613
K-number listed on FDA's recall record- Z-1389-2020 — 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 include the cuvette used with equipment to monitor blood.
- Z-0664-2018 — 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.
- Z-2783-2017 — SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
- Z-2784-2017 — SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
- Z-2785-2017 — SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
- Z-2786-2017 — SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
- Z-2787-2017 — SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
- Z-2788-2017 — 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
- Z-2789-2017 — SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
- Z-2790-2017 — SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
- Z-2791-2017 — STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
- Z-2792-2017 — SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
- Z-2793-2017 — SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
- Z-2794-2017 — SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
- Z-2795-2017 — SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
- Z-2796-2017 — NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
- Z-2797-2017 — NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
- Z-2798-2017 — NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981613.
Data sourced from openFDA. This site is unofficial and independent of the FDA.