510k
Database
Specialties
Anesthesiology
409
Cardiovascular
1235
Chemistry
308
Dental
930
Ear, Nose, Throat
179
Gastroenterology & Urology
726
General & Plastic Surgery
1585
General Hospital
981
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113
Immunology
79
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4
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400
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689
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297
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183
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2239
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43
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370
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1811
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138
Categories
GEX
Powered Laser Surgical Instrument
260
LLZ
System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
224
GEI
Electrosurgical, Cutting &...
221
HRS
Plate, Fixation, Bone
219
OLO
Orthopedic Stereotaxic Instrument
183
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
148
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Cook Vascular, Inc.
Medical Device Manufacturer
·
US , Leechburg , PA
Cook Vascular, Inc. - FDA 510(k) Cleared Devices
12 submissions
·
12 cleared
·
Since 2001
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cook Vascular, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 02, 2009
COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET
K083482
·
FPA
General Hospital
·
129d
Cleared
Sep 30, 2008
COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT
K081425
·
LJT
General Hospital
·
132d
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12
Cardiovascular
6
Radiology
3
General Hospital
2
General & Plastic Surgery
1