510k
Database
Specialties
Anesthesiology
208
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743
Chemistry
187
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472
Ear, Nose, Throat
92
Gastroenterology & Urology
398
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783
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479
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77
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64
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1
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278
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309
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121
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81
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1484
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26
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155
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1103
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95
Categories
IYN
System, Imaging, Pulsed Doppler,...
168
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
GEX
Powered Laser Surgical Instrument
128
LLZ
System, Image Processing,...
126
QIH
Automated Radiological Image...
113
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
98
NKB
Thoracolumbosacral Pedicle Screw...
93
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Xablecath, Inc.
Medical Device Manufacturer
·
US , Salt Lake City , UT
Xablecath, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2017
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Xablecath, Inc.
Cardiovascular
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 21, 2019
XableCath Crossing Catheter
K183357
·
PDU
Cardiovascular
·
48d
Cleared
May 15, 2018
XableCath Support Catheter Product Family
K180986
·
DQY
Cardiovascular
·
29d
Cleared
Sep 07, 2017
XableCath Support Catheter
K170041
·
DQY
Cardiovascular
·
245d
Filters
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3
Cardiovascular
3