Cordis Neurovascular, Inc.: FDA clearances and approvals
Cordis Neurovascular, Inc. has 38 FDA 510(k) clearances (first 1994, latest 2008), across 6 product codes in 2 review panels. Median 510(k) review time: 87 days. openFDA lists 3 product recalls by a recalling firm named Cordis Neurovascular, 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 13 | 13 |
| KRA | Catheter, Continuous Flush | 13 | 13 |
| DQX | Wire, Guide, Catheter | 4 | 4 |
| DQY | Catheter, Percutaneous | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DXC | Clamp, Vascular | 1 | 1 |
Review panels
- Cardiovascular (25)
- Neurology (13)
Most recent Cordis Neurovascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082324 | TRUFILL DCS SYRINGE | HCG | 2008-09-12 | 29 |
| K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT | HCG | 2008-05-02 | 28 |
| K071962 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) | HCG | 2007-09-26 | 72 |
| K070279 | MODIFICATION TO HYPERTRANSIT INFUSION CATHETER | KRA | 2007-03-14 | 44 |
| K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | 2006-12-07 | 41 |
| K053197 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION | HCG | 2005-12-15 | 29 |
| K043538 | HYPERTRANSIT INFUSION CATHETER | KRA | 2005-04-18 | 117 |
| K032553 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | 2003-09-23 | 35 |
| K030963 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | 2003-06-20 | 85 |
| K021591 | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | KRA | 2002-05-22 | 7 |
28 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2006-08-11.
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 Cordis Neurovascular, Inc. have?
Cordis Neurovascular, Inc. has 38 FDA 510(k) clearances (first 1994, latest 2008), across 6 product codes in 2 review panels.
How long does FDA take to clear Cordis Neurovascular, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Cordis Neurovascular, Inc.'s cleared 510(k)s is 87 days.
What devices does Cordis Neurovascular, Inc. make?
Its most frequent FDA product codes are HCG (Device, Neurovascular Embolization, 13); KRA (Catheter, Continuous Flush, 13); DQX (Wire, Guide, Catheter, 4).
Has Cordis Neurovascular, Inc. had device recalls?
openFDA lists 3 product recalls in 2 recall events by a recalling firm whose name matches Cordis Neurovascular, Inc; the most recent began 2006-08-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 38 Cordis Neurovascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HCG, Cordis Neurovascular, 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.