510k
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542
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1683
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370
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1341
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250
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979
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2201
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2052
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126
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99
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8
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472
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969
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436
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279
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2961
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52
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515
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2457
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155
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Polymer Patient Examination Glove
409
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System, Image Processing,...
391
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358
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356
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307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
281
QIH
Automated Radiological Image...
276
OLO
Orthopedic Stereotaxic Instrument
231
MAX
Intervertebral Fusion Device...
221
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AngioSafe, Inc.
Medical Device Manufacturer
·
US , San Jose , CA
AngioSafe, Inc. - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2025
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - AngioSafe, Inc.
Cardiovascular
✕
1
devices
1-1 of 1
Filters
Cleared
CT
Sep 22, 2025
Santreva™-ATK Endovascular Revasculariztion Catheter
K252315
·
PDU
Cardiovascular
·
59d
Filters
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1
Cardiovascular
1