Medical Device Manufacturer · US , Miami Lakes , FL

Cordis Neurovascular, Inc. - FDA 510(k) Cleared Devices

37 submissions · 37 cleared · Since 1994

Recent clearances: TRUFILL DCS SYRINGE, TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT, VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)

37
Total
37
Cleared
0
Denied

FDA 510(k) Regulatory Record - Cordis Neurovascular, Inc. Cardiovascular

25 devices
1-25 of 25
Cleared Mar 14, 2007
MODIFICATION TO HYPERTRANSIT INFUSION CATHETER
K070279 · KRA
Cardiovascular · 44d
Cleared Apr 18, 2005
HYPERTRANSIT INFUSION CATHETER
K043538 · KRA
Cardiovascular · 117d
Cleared May 22, 2002
PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT...
K021591 · KRA
Cardiovascular · 7d
Cleared Mar 27, 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · KRA
Cardiovascular · 23d
Cleared Mar 01, 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · DQX
Cardiovascular · 8d
Cleared Jan 08, 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · KRA
Cardiovascular · 19d
Cleared Apr 14, 2000
AGILITY STEERABLE GUIDEWIRE
K001033 · DQX
Cardiovascular · 14d
Cleared Oct 28, 1999
PROWLER PLUS INFUSION CATHETER
K993266 · KRA
Cardiovascular · 28d
Cleared Sep 23, 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · DQX
Cardiovascular · 133d
Cleared Aug 10, 1999
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · DXC
Cardiovascular · 259d
Cleared Sep 17, 1998
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
K983003 · KRA
Cardiovascular · 20d
Cleared Feb 10, 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · KRA
Cardiovascular · 90d
Cleared Nov 04, 1997
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · KRA
Cardiovascular · 120d
Cleared Jul 23, 1997
ENVOY GUIDING CATHETER
K965247 · DQY
Cardiovascular · 211d
Cleared Jul 14, 1997
FG INFUSION CATHETER
K971306 · KRA
Cardiovascular · 97d
Cleared Mar 21, 1997
CES INFUSION CATHETER
K965181 · KRA
Cardiovascular · 87d
Cleared Mar 11, 1996
ESSENCE GUIDEWIRE
K955637 · DQX
Cardiovascular · 91d
Cleared Dec 22, 1995
TRANSIT INFUSION CATHETER WITH SIDEHOLES
K954949 · KRA
Cardiovascular · 53d
Cleared Oct 23, 1995
5F ENVOY GUIDING CATHETER (MODIFICATION)
K954251 · DQY
Cardiovascular · 60d
Cleared Aug 21, 1995
TRANSIT INFUSION CATHETER
K952874 · KRA
Cardiovascular · 90d
Cleared Aug 08, 1995
TRANSIT-2 INFUSION CATHETER
K950910 · DQO
Cardiovascular · 176d
Cleared May 16, 1995
TRANSIT-2 INFUSION CATHETER
K950909 · DQO
Cardiovascular · 91d
Cleared Feb 03, 1995
5F ENVOY(TM) GUIDING CATHETER
K945705 · DQY
Cardiovascular · 87d
Cleared Jul 18, 1994
TRANSIT INFUSION CATHETER (NEUROVASCULAR USE)
K936282 · DQO
Cardiovascular · 200d
Cleared Mar 30, 1994
ENVOY GUIDING CATHETER
K940187 · DQY
Cardiovascular · 76d
Filters