Cordis Neurovascular, Inc.
Miami Lake, FL, US
Cordis Neurovascular, Inc. appears in FDA device records in Miami Lake, FL. FDA records list 38 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Cordis Neurovascular, Inc. between 1994 and 2008. The busiest year on record is 1995, with 7. The most recent is 2008, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 2 |
| 1995 | 7 |
| 1996 | 1 |
| 1997 | 6 |
| 1998 | 3 |
| 1999 | 4 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 3 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K082324 | TRUFILL DCS SYRINGE | HCG | Substantially Equivalent | |
| K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT | HCG | Substantially Equivalent | |
| K071962 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) | HCG | Substantially Equivalent | |
| K070279 | MODIFICATION TO HYPERTRANSIT INFUSION CATHETER | KRA | Substantially Equivalent | |
| K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | |
| K053197 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION | HCG | Substantially Equivalent | |
| K043538 | HYPERTRANSIT INFUSION CATHETER | KRA | Substantially Equivalent | |
| K032553 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | |
| K030963 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | |
| K021591 | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | KRA | Substantially Equivalent | |
| K020680 | PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS | KRA | Substantially Equivalent | |
| K014041 | TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM | HCG | Substantially Equivalent | |
| K010511 | MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES | DQX | Substantially Equivalent | |
| K003925 | PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS | KRA | Substantially Equivalent | |
| K001033 | AGILITY STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | |
| K993266 | PROWLER PLUS INFUSION CATHETER | KRA | Substantially Equivalent | |
| K991646 | AGILITY STEERABLE GUIDEWIRE | DQX | Substantially Equivalent | |
| K984214 | CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER | DXC | Substantially Equivalent | |
| K983483 | VASCULAR OCCLUSION SYSTEM | HCG | Substantially Equivalent | |
| K983003 | 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS | KRA | Substantially Equivalent | |
| K972881 | CES VASCULAR OCCLUSION SYSTEM | HCG | Substantially Equivalent | |
| K974222 | CES MASSTRANSIT INFUSION CATHETER | KRA | Substantially Equivalent | |
| K972518 | TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER | KRA | Substantially Equivalent | |
| K965247 | ENVOY GUIDING CATHETER | DQY | Substantially Equivalent | |
| K971306 | FG INFUSION CATHETER | KRA | Substantially Equivalent | |
| K965181 | CES INFUSION CATHETER | KRA | Substantially Equivalent | |
| K965174 | TRUFILL PVA PARTICLES | HCG | Substantially Equivalent | |
| K964367 | CES VASCULAR OCCLUSION SYSTEM | HCG | Substantially Equivalent | |
| K955637 | ESSENCE GUIDEWIRE | DQX | Substantially Equivalent | |
| K954949 | TRANSIT INFUSION CATHETER WITH SIDEHOLES | KRA | Substantially Equivalent | |
| K954251 | 5F ENVOY GUIDING CATHETER (MODIFICATION) | DQY | Substantially Equivalent | |
| K952874 | TRANSIT INFUSION CATHETER | KRA | Substantially Equivalent | |
| K951314 | TRUEFILL PVA PARTICLES | HCG | Substantially Equivalent | |
| K950910 | TRANSIT-2 INFUSION CATHETER | DQO | Substantially Equivalent | |
| K950909 | TRANSIT-2 INFUSION CATHETER | DQO | Substantially Equivalent | |
| K945705 | 5F ENVOY(TM) GUIDING CATHETER | DQY | Substantially Equivalent | |
| K936282 | TRANSIT INFUSION CATHETER (NEUROVASCULAR USE) | DQO | Substantially Equivalent | |
| K940187 | ENVOY GUIDING CATHETER | DQY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1483-06 | Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters. | Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch. | Terminated | ||
| Z-1482-06 | Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. | Sterility (package integrity) compromised-Cordis Neurovascular, Inc. discovered, during internal testing, that some catheters within the affected lots of CNV preshaped PROWLER and pre-shaped PROWLER SELECT Infusion Catheters may have a pinhole or tear in the Mylar pouch, which may result in a compromise of the sterility inside the pouch. | Terminated | ||
| Z-0018-04 | Product is labeled as Cordis Pre-shaped Prowler Plus MP Infusion Catheter (3 F proximal OD, 2.3 F Distal OD, 45 cm distal length, total length 155 cm) with an MP (45 degree) dual marker band tip. Also the package states that it is distributed by Cordis Endovascular systems, Inc, Miami, FL 33102 a Johnson & Johnson Company. | These catheters have J-shape tips instead of the labeled MP (multipurpose) tips and also are packed into the incorrect tip tray. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain