510k
Database
Specialties
Anesthesiology
325
Cardiovascular
1045
Chemistry
264
Dental
784
Ear, Nose, Throat
147
Gastroenterology & Urology
609
General & Plastic Surgery
1291
General Hospital
734
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
363
Neurology
553
Obstetrics & Gynecology
240
Ophthalmic
148
Orthopedic
1987
Pathology
38
Physical Medicine
307
Radiology
1550
Toxicology
128
Categories
GEX
Powered Laser Surgical Instrument
227
IYN
System, Imaging, Pulsed Doppler,...
205
HRS
Plate, Fixation, Bone
204
QIH
Automated Radiological Image...
202
LLZ
System, Image Processing,...
191
GEI
Electrosurgical, Cutting &...
181
OLO
Orthopedic Stereotaxic Instrument
166
NHA
Abutment, Implant, Dental,...
151
MAX
Intervertebral Fusion Device...
136
NKB
Thoracolumbosacral Pedicle Screw...
130
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Cardiovascular Systems, Inc.
Medical Device Manufacturer
·
US , Saint Paul , MN
Cardiovascular Systems, Inc. - FDA 510(k) Cleared Devices
26 submissions
·
26 cleared
·
Since 2007
26
Total
26
Cleared
0
Denied
26
devices
26-26 of 26
Filters
1
2
Cleared
Aug 22, 2007
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM
K071350
·
MCW
Cardiovascular
·
100d
1
2
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26
Cardiovascular
26