Avecor Cardiovascular, Inc.: FDA clearances and approvals
Avecor Cardiovascular, Inc. has 9 FDA 510(k) clearances (first 1993, latest 1998), across 6 product codes in 1 review panel. Median 510(k) review time: 169 days.
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 | 3 | 3 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 | 2 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 1 | 1 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| KRJ | Filter, Prebypass, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent Avecor Cardiovascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973760 | AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE | DTZ | 1998-02-18 | 139 |
| K964017 | AFFINITY BLOOD PUMP SYSTEM | DTQ | 1997-08-05 | 302 |
| K971105 | MYOTHERM (TM) XP CARDIOPLEGIA DELIVERY SYSTEM | DTN | 1997-07-11 | 107 |
| K952532 | AFFINITY ARTERIAL BLOOD FILTER | DTM | 1995-10-06 | 127 |
| K940126 | AVECOR PRE-BYPASS FILTER | KRJ | 1994-06-28 | 169 |
| K936003 | AFFINITY CVR | DTN | 1994-06-20 | 186 |
| K935717 | AFFINITY VENOUS RESERVIOR BAG | DTN | 1994-05-10 | 161 |
| K932252 | AFFINITY HOLLOW FIBER OXYGENATOR | DTZ | 1993-11-19 | 177 |
| K924529 | SIGNATURE(TM) CUSTOM TUBING PACK | DWF | 1993-06-23 | 288 |
Recalls
openFDA lists no recalls under a recalling firm named Avecor Cardiovascular, Inc..
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 Avecor Cardiovascular, Inc. have?
Avecor Cardiovascular, Inc. has 9 FDA 510(k) clearances (first 1993, latest 1998), across 6 product codes in 1 review panel.
How long does FDA take to clear Avecor Cardiovascular, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Avecor Cardiovascular, Inc.'s cleared 510(k)s is 169 days.
What devices does Avecor Cardiovascular, Inc. make?
Its most frequent FDA product codes are DTN (Reservoir, Blood, Cardiopulmonary Bypass, 3); DTZ (Oxygenator, Cardiopulmonary Bypass, 2); DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line, 1).
Has Avecor Cardiovascular, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Avecor Cardiovascular, Inc. Related entities may recall under other names.
Next steps
- See all 9 Avecor Cardiovascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DTN, Avecor 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.