Company ยท US
Cordis Neurovascular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2008. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2008 | K082324 | TRUFILL DCS SYRINGE Cordis Neurovascular, Inc. | HCG |
| May 2, 2008 | K080967 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT Cordis Neurovascular, Inc. | HCG |
| Sep 26, 2007 | K071962 | VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER) Cordis Neurovascular, Inc. | HCG |
| Mar 14, 2007 | K070279 | MODIFICATION TO HYPERTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Dec 7, 2006 | K063254 | THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. | HCG |
| Dec 15, 2005 | K053197 | TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION Cordis Neurovascular, Inc. | HCG |
| Apr 18, 2005 | K043538 | HYPERTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Sep 23, 2003 | K032553 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. | HCG |
| Jun 20, 2003 | K030963 | TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM Cordis Neurovascular, Inc. | HCG |
| May 22, 2002 | K021591 | PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS Cordis Neurovascular, Inc. | KRA |
| Mar 27, 2002 | K020680 | PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS Cordis Neurovascular, Inc. | KRA |
| Mar 7, 2002 | K014041 | TRUFILL DCS DETACHABLE COIL AND FRUFILL DCS SYRINGE, ALSO KNOWN AS THE TRUFILL DCS DETACHABLE COIL SYSTEM Cordis Neurovascular | HCG |
| Mar 1, 2001 | K010511 | MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES Cordis Neurovascular, Inc. | DQX |
| Jan 8, 2001 | K003925 | PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS Cordis Neurovascular, Inc. | KRA |
| Apr 14, 2000 | K001033 | AGILITY STEERABLE GUIDEWIRE Cordis Neurovascular, Inc. | DQX |
| Oct 28, 1999 | K993266 | PROWLER PLUS INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Sep 23, 1999 | K991646 | AGILITY STEERABLE GUIDEWIRE Cordis Neurovascular, Inc. | DQX |
| Aug 10, 1999 | K984214 | CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER Cordis Neurovascular, Inc. | DXC |
| Mar 24, 1999 | K983483 | VASCULAR OCCLUSION SYSTEM Cordis Neurovascular, Inc. | HCG |
| Sep 17, 1998 | K983003 | 1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS Cordis Neurovascular, Inc. | KRA |
| Jun 4, 1998 | K972881 | CES VASCULAR OCCLUSION SYSTEM Cordis Neurovascular, Inc. | HCG |
| Feb 10, 1998 | K974222 | CES MASSTRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Nov 4, 1997 | K972518 | TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Jul 23, 1997 | K965247 | ENVOY GUIDING CATHETER Cordis Neurovascular, Inc. | DQY |
| Jul 14, 1997 | K971306 | FG INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Mar 21, 1997 | K965181 | CES INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Mar 21, 1997 | K965174 | TRUFILL PVA PARTICLES Cordis Neurovascular, Inc. | HCG |
| Jan 30, 1997 | K964367 | CES VASCULAR OCCLUSION SYSTEM Cordis Neurovascular, Inc. | HCG |
| Mar 11, 1996 | K955637 | ESSENCE GUIDEWIRE Cordis Neurovascular, Inc. | DQX |
| Dec 22, 1995 | K954949 | TRANSIT INFUSION CATHETER WITH SIDEHOLES Cordis Neurovascular, Inc. | KRA |
| Oct 23, 1995 | K954251 | 5F ENVOY GUIDING CATHETER (MODIFICATION) Cordis Neurovascular, Inc. | DQY |
| Aug 21, 1995 | K952874 | TRANSIT INFUSION CATHETER Cordis Neurovascular, Inc. | KRA |
| Aug 8, 1995 | K951314 | TRUEFILL PVA PARTICLES Cordis Neurovascular, Inc. | HCG |
| Aug 8, 1995 | K950910 | TRANSIT-2 INFUSION CATHETER Cordis Neurovascular, Inc. | DQO |
| May 16, 1995 | K950909 | TRANSIT-2 INFUSION CATHETER Cordis Neurovascular, Inc. | DQO |
| Feb 3, 1995 | K945705 | 5F ENVOY(TM) GUIDING CATHETER Cordis Neurovascular, Inc. | DQY |
| Jul 18, 1994 | K936282 | TRANSIT INFUSION CATHETER (NEUROVASCULAR USE) Cordis Neurovascular, Inc. | DQO |
| Mar 30, 1994 | K940187 | ENVOY GUIDING CATHETER Cordis Neurovascular, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2006 | Cordis Neurovascular, Inc. Cordis Neurovascular Pre-Shaped Prowler Select Infusion Catheters. Terminated |
KRA | K021591 |
| Sep 2, 2006 | Cordis Neurovascular, Inc. Cordis Neurovascular Pre-Shaped PROWLER Infusion Catheters. Terminated |
KRA | K021591 |
| Oct 15, 2003 | Cordis Neurovascular, Inc. 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. Als Terminated |
K003925 |