Cobe Cardiovascular, Inc.: FDA clearances and approvals
Cobe Cardiovascular, Inc. has 43 FDA 510(k) clearances (first 1992, latest 2005), across 15 product codes in 2 review panels. Median 510(k) review time: 108 days. openFDA lists 21 product recalls by a recalling firm named Cobe Cardiovascular, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 9 | 9 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 8 | 8 |
| CAC | Apparatus, Autotransfusion | 7 | 7 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 3 | 3 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 | 3 |
| DTP | Defoamer, Cardiopulmonary Bypass | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 2 | 2 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
Plus 5 more product codes.
Review panels
- Cardiovascular (42)
- Clinical Chemistry (1)
Most recent Cobe Cardiovascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050111 | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG | DTN | 2005-03-08 | 49 |
| K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | JQC | 2004-11-19 | 67 |
| K040184 | DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER | DTM | 2004-02-26 | 31 |
| K033641 | SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 | DTN | 2003-12-11 | 21 |
| K030462 | COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 | KFM | 2003-03-06 | 22 |
| K021830 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | DTR | 2002-07-02 | 28 |
| K011835 | COBE REVOLUTION | KFM | 2002-02-12 | 245 |
| K013480 | COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | 2001-11-16 | 28 |
| K012763 | SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM | DRT | 2001-11-15 | 90 |
| K001509 | STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE | DWF | 2001-10-26 | 529 |
33 earlier clearances. See the full list in Caduvo.
Recalls
21 product recalls in 6 recall events; 0 initiated in the last five years. Most recent: 2006-08-04.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cobe Cardiovascular, Inc. have?
Cobe Cardiovascular, Inc. has 43 FDA 510(k) clearances (first 1992, latest 2005), across 15 product codes in 2 review panels.
How long does FDA take to clear Cobe Cardiovascular, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cobe Cardiovascular, Inc.'s cleared 510(k)s is 108 days.
What devices does Cobe Cardiovascular, Inc. make?
Its most frequent FDA product codes are DTN (Reservoir, Blood, Cardiopulmonary Bypass, 9); DTZ (Oxygenator, Cardiopulmonary Bypass, 8); CAC (Apparatus, Autotransfusion, 7).
Has Cobe Cardiovascular, Inc. had device recalls?
openFDA lists 21 product recalls in 6 recall events by a recalling firm whose name matches Cobe Cardiovascular, Inc; the most recent began 2006-08-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 43 Cobe Cardiovascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTN, Cobe Cardiovascular, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.