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Innolitics
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
MOF
Guide, Wire, Catheter, Neurovasculature
2
Product Code
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
K
24
1768
Broadway 8 Catheter (BRW084132-01)
2
Cleared 510(K)
K
24
1637
Echo Intracranial Base Catheter
2
Cleared 510(K)
K
24
2033
Access25™ Delivery Microcatheter
2
Cleared 510(K)
K
24
0971
87 NeuGlide Catheter
2
Cleared 510(K)
K
24
2301
Socrates 38 Catheter
2
Cleared 510(K)
K
24
0746
Neurovascular Access System Family
2
Cleared 510(K)
K
24
0711
Zipline Access Catheter
2
Cleared 510(K)
K
24
1244
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
2
Cleared 510(K)
K
24
0529
8F Modified Sheath System
2
Cleared 510(K)
K
23
4074
Next Generation Access Catheter
2
Cleared 510(K)
Show All 66 Submissions
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 17 January 2025 at 11:05 pm
NE
/
subpart-b—cardiovascular-diagnostic-devices
/
QJP
/
K242301
View Source
Socrates 38 Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242301
510(k) Type
Traditional
Applicant
Scientia Vascular Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2024
Days to Decision
124 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
NDQ
System, Catheter Or Guidewire, Steerable (Magnetic)
NRY
Catheter, Thrombus Retriever
NUI
Ultrasound, Infusion, System
QBE
Cranial Sound Monitor
QJP
Catheter, Percutaneous, Neurovasculature
K
24
1768
Broadway 8 Catheter (BRW084132-01)
K
24
1637
Echo Intracranial Base Catheter
K
24
2033
Access25™ Delivery Microcatheter
K
24
0971
87 NeuGlide Catheter
K
24
2301
Socrates 38 Catheter
K
24
0746
Neurovascular Access System Family
K
24
0711
Zipline Access Catheter
K
24
1244
CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter
K
24
0529
8F Modified Sheath System
K
23
4074
Next Generation Access Catheter
Show All 66 Submissions
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
/
QJP
/
K242301
View Source
Socrates 38 Catheter
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242301
510(k) Type
Traditional
Applicant
Scientia Vascular Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/4/2024
Days to Decision
124 days
Submission Type
Summary