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Innolitics
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Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
NAJ
Agents, Embolic, For Treatment Of Uterine Fibroids
2
Product Code
K
23
3813
Bearing nsPVA Express (S100EP); Bearing nsPVA Express (S200EP); Bearing nsPVA Express (S300EP); Bearing nsPVA Express (S400EP); Bearing nsPVA Express (S600EP); Bearing nsPVA Express (S800EP); Bearing nsPVA Express (S1100EP)
2
Cleared 510(K)
K
17
3871
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
2
Cleared 510(K)
K
13
3447
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
2
Cleared 510(K)
K
13
0259
BEARING NSPVA EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
10
0663
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
2
Cleared 510(K)
K
08
1768
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
2
Cleared 510(K)
K
03
0966
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
2
Cleared 510(K)
K
02
1397
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
2
Cleared 510(K)
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
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 16 August 2024 at 11:05 pm
OB
/
subpart-d—cardiovascular-prosthetic-devices
/
NAJ
/
K173871
View Source
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173871
510(k) Type
Traditional
Applicant
Suzhou Hengrui Callisyn Biomedical Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/17/2018
Days to Decision
271 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
Subpart D—Cardiovascular Prosthetic Devices
NAJ
Agents, Embolic, For Treatment Of Uterine Fibroids
K
23
3813
Bearing nsPVA Express (S100EP); Bearing nsPVA Express (S200EP); Bearing nsPVA Express (S300EP); Bearing nsPVA Express (S400EP); Bearing nsPVA Express (S600EP); Bearing nsPVA Express (S800EP); Bearing nsPVA Express (S1100EP)
K
17
3871
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
K
13
3447
EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES
K
13
0259
BEARING NSPVA EMBOLIZATION PARTICLES
K
10
0663
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321
K
08
1768
COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES
K
03
0966
CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER
K
02
1397
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-d—cardiovascular-prosthetic-devices
/
NAJ
/
K173871
View Source
CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K173871
510(k) Type
Traditional
Applicant
Suzhou Hengrui Callisyn Biomedical Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
9/17/2018
Days to Decision
271 days
Submission Type
Summary