510k
Database
Specialties
Anesthesiology
531
Cardiovascular
1642
Chemistry
359
Dental
1314
Ear, Nose, Throat
242
Gastroenterology & Urology
954
General & Plastic Surgery
2166
General Hospital
2031
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
Neurology
951
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2819
Pathology
52
Physical Medicine
515
Radiology
2400
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
379
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
299
IYN
System, Imaging, Pulsed Doppler,...
283
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
208
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Acist Medical Systems, Inc.
Medical Device Manufacturer
·
US , Eden Prairie , MN
Acist Medical Systems, Inc. - FDA 510(k) Cleared Devices
14 submissions
·
14 cleared
·
Since 2001
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Acist Medical Systems, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 17, 2020
ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
K203004
·
DXT
General Hospital
·
77d
Cleared
Jul 18, 2019
ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit,...
K191060
·
DXT
General Hospital
·
87d
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14
Cardiovascular
12
General Hospital
2