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Review Panel
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Review Panel
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Review Panel
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
MOF
Guide, Wire, Catheter, Neurovasculature
2
Product Code
K
24
0871
Synxess Neurovascular Guidewire
2
Cleared 510(K)
K
23
3791
Drivewire 24 Guidewire
2
Cleared 510(K)
K
23
1954
Aristotle 18 Guidewire; Aristotle 24 Guidewire
2
Cleared 510(K)
K
22
2690
SmartGUIDE deflectable hydrophilic guidewire
2
Cleared 510(K)
K
22
0398
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
2
Cleared 510(K)
K
22
2437
Aristotle Colossus Guidewire
2
Cleared 510(K)
K
22
0934
RADIFOCUS Torque Device
2
Cleared 510(K)
K
20
0374
Columbus Guidewire
2
Cleared 510(K)
K
20
2522
Synchro SELECT Guidewire
2
Cleared 510(K)
K
20
1487
Traxcess 7 Mini Guidewire
2
Cleared 510(K)
K
20
0547
Traxcess 14 SELECT Guidewire
2
Cleared 510(K)
K
19
1714
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
2
Cleared 510(K)
K
19
0843
Synchro2 Support Guidewire
2
Cleared 510(K)
K
18
3608
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
2
Cleared 510(K)
K
18
3070
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
2
Cleared 510(K)
K
18
2337
HYBRID Guidewire
2
Cleared 510(K)
K
18
1828
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
2
Cleared 510(K)
K
17
1613
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
2
Cleared 510(K)
K
16
3154
Traxcess 7 Mini XSoft Guidewire
2
Cleared 510(K)
K
16
1912
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
2
Cleared 510(K)
K
16
1803
Traxcess .007 Mini Guidewire
2
Cleared 510(K)
K
16
0659
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
2
Cleared 510(K)
K
15
3053
Traxcess Pro 14 Guidewire
2
Cleared 510(K)
K
15
1825
Viradius Neurowire
2
Cleared 510(K)
K
14
1751
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
2
Cleared 510(K)
K
13
3725
TRAXCESS 14 GUIDEWIRE
2
Cleared 510(K)
K
13
3625
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
2
Cleared 510(K)
K
11
2979
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
2
Cleared 510(K)
K
11
0584
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
2
Cleared 510(K)
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
2
Product Code
NRY
Catheter, Thrombus Retriever
2
Product Code
NUI
Ultrasound, Infusion, System
2
Product Code
QBE
Cranial Sound Monitor
2
Product Code
QJP
Catheter, Percutaneous, Neurovasculature
2
Product Code
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
NE
/
subpart-b—cardiovascular-diagnostic-devices
/
MOF
/
K183608
View Source
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183608
510(k) Type
Traditional
Applicant
Scientia Vascular LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/22/2019
Days to Decision
86 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
MOF
Guide, Wire, Catheter, Neurovasculature
K
24
0871
Synxess Neurovascular Guidewire
K
23
3791
Drivewire 24 Guidewire
K
23
1954
Aristotle 18 Guidewire; Aristotle 24 Guidewire
K
22
2690
SmartGUIDE deflectable hydrophilic guidewire
K
22
0398
Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire
K
22
2437
Aristotle Colossus Guidewire
K
22
0934
RADIFOCUS Torque Device
K
20
0374
Columbus Guidewire
K
20
2522
Synchro SELECT Guidewire
K
20
1487
Traxcess 7 Mini Guidewire
K
20
0547
Traxcess 14 SELECT Guidewire
K
19
1714
ASAHI Neurovascular Guide Wire CHIKAI X 014 soft
K
19
0843
Synchro2 Support Guidewire
K
18
3608
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
K
18
3070
ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
K
18
2337
HYBRID Guidewire
K
18
1828
Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile
K
17
1613
ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip
K
16
3154
Traxcess 7 Mini XSoft Guidewire
K
16
1912
ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip
K
16
1803
Traxcess .007 Mini Guidewire
K
16
0659
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
K
15
3053
Traxcess Pro 14 Guidewire
K
15
1825
Viradius Neurowire
K
14
1751
ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI 008, ASAHI NEUROVASCULAR GUIDE WIRE ASAHI CHIKAI BLACK, ASAHI NEUROVASCULAR
K
13
3725
TRAXCESS 14 GUIDEWIRE
K
13
3625
AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD &
K
11
2979
ASAHI CHIKAI 10 NEUROVASCULAR GUIDE WIRE
K
11
0584
ASAHI CHIKAI NEUROVASCULAR GUIDE WIRE
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
NRY
Catheter, Thrombus Retriever
NUI
Ultrasound, Infusion, System
QBE
Cranial Sound Monitor
QJP
Catheter, Percutaneous, Neurovasculature
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—cardiovascular-diagnostic-devices
/
MOF
/
K183608
View Source
Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183608
510(k) Type
Traditional
Applicant
Scientia Vascular LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/22/2019
Days to Decision
86 days
Submission Type
Summary