Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cordis Neurovascular, Inc. · Predicate Candidate Screening
37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
200 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082324 | TRUFILL DCS SYRINGE | Cordis Neurovascular, Inc. | 2008-09-12 | 29 | 0 |
| K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR | Cordis Neurovascular, Inc. | 2008-05-02 | 28 | 0 |
| K071962 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUS | Cordis Neurovascular, Inc. | 2007-09-26 | 72 | 0 |
| K070279 | MODIFICATION TO HYPERTRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 2007-03-14 | 44 | 0 |
| K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBI | Cordis Neurovascular, Inc. | 2006-12-07 | 41 | 0 |
| K053197 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION | Cordis Neurovascular, Inc. | 2005-12-15 | 29 | 0 |
| K043538 | HYPERTRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 2005-04-18 | 117 | 0 |
| K032553 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, A | Cordis Neurovascular, Inc. | 2003-09-23 | 35 | 0 |
| K030963 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, A | Cordis Neurovascular, Inc. | 2003-06-20 | 85 | 0 |
| K021591 | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AN | Cordis Neurovascular, Inc. | 2002-05-22 | 7 | 2 |
| K020680 | PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT | Cordis Neurovascular, Inc. | 2002-03-27 | 23 | 0 |
| K010511 | MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES | Cordis Neurovascular, Inc. | 2001-03-01 | 8 | 0 |
| K003925 | PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS | Cordis Neurovascular, Inc. | 2001-01-08 | 19 | 1 |
| K001033 | AGILITY STEERABLE GUIDEWIRE | Cordis Neurovascular, Inc. | 2000-04-14 | 14 | 0 |
| K993266 | PROWLER PLUS INFUSION CATHETER | Cordis Neurovascular, Inc. | 1999-10-28 | 28 | 0 |
| K991646 | AGILITY STEERABLE GUIDEWIRE | Cordis Neurovascular, Inc. | 1999-09-23 | 133 | 0 |
| K984214 | CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER | Cordis Neurovascular, Inc. | 1999-08-10 | 259 | 0 |
| K983483 | VASCULAR OCCLUSION SYSTEM | Cordis Neurovascular, Inc. | 1999-03-24 | 170 | 0 |
| K983003 | 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS | Cordis Neurovascular, Inc. | 1998-09-17 | 20 | 1 |
| K972881 | CES VASCULAR OCCLUSION SYSTEM | Cordis Neurovascular, Inc. | 1998-06-04 | 303 | 0 |
| K974222 | CES MASSTRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 1998-02-10 | 90 | 0 |
| K972518 | TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER | Cordis Neurovascular, Inc. | 1997-11-04 | 120 | 0 |
| K965247 | ENVOY GUIDING CATHETER | Cordis Neurovascular, Inc. | 1997-07-23 | 211 | 0 |
| K971306 | FG INFUSION CATHETER | Cordis Neurovascular, Inc. | 1997-07-14 | 97 | 0 |
| K965181 | CES INFUSION CATHETER | Cordis Neurovascular, Inc. | 1997-03-21 | 87 | 0 |
| K965174 | TRUFILL PVA PARTICLES | Cordis Neurovascular, Inc. | 1997-03-21 | 87 | 0 |
| K964367 | CES VASCULAR OCCLUSION SYSTEM | Cordis Neurovascular, Inc. | 1997-01-30 | 90 | 0 |
| K955637 | ESSENCE GUIDEWIRE | Cordis Neurovascular, Inc. | 1996-03-11 | 91 | 0 |
| K954949 | TRANSIT INFUSION CATHETER WITH SIDEHOLES | Cordis Neurovascular, Inc. | 1995-12-22 | 53 | 0 |
| K954251 | 5F ENVOY GUIDING CATHETER (MODIFICATION) | Cordis Neurovascular, Inc. | 1995-10-23 | 60 | 0 |
| K952874 | TRANSIT INFUSION CATHETER | Cordis Neurovascular, Inc. | 1995-08-21 | 90 | 0 |
| K950910 | TRANSIT-2 INFUSION CATHETER | Cordis Neurovascular, Inc. | 1995-08-08 | 176 | 0 |
| K951314 | TRUEFILL PVA PARTICLES | Cordis Neurovascular, Inc. | 1995-08-08 | 138 | 0 |
| K950909 | TRANSIT-2 INFUSION CATHETER | Cordis Neurovascular, Inc. | 1995-05-16 | 91 | 0 |
| K945705 | 5F ENVOY(TM) GUIDING CATHETER | Cordis Neurovascular, Inc. | 1995-02-03 | 87 | 0 |
| K936282 | TRANSIT INFUSION CATHETER (NEUROVASCULAR USE) | Cordis Neurovascular, Inc. | 1994-07-18 | 200 | 0 |
| K940187 | ENVOY GUIDING CATHETER | Cordis Neurovascular, Inc. | 1994-03-30 | 76 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda