FDA.reportPublic FDA data

Embosphere®

Primary DI
00884450403204
Brand
Embosphere®
Company
BIOSPHERE MEDICAL
Model
00884450403204
Catalog number
S220GH/C
Published
2019-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HCGDevice, Neurovascular Embolization
KRDDevice, Vascular, for Promoting Embolization
NAJAgents, Embolic, For Treatment Of Uterine Fibroids
NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2
NAJAgents, Embolic, For Treatment Of Uterine FibroidsCardiovascular2
NOYAgents, Embolic, For Treatment Of Benign Prostatic HyperplasiaGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181300000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181300000Embosphere MicrospheresBiosphere Medical, S.A.2018-07-16KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450403201PackageGS15In Commercial Distribution
00884450403204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445040320110884450403201
00884450403204008844504032048844504032040884450403204

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA non-bioabsorbable, implantable bead/microsphere intended to be introduced into the peripheral vasculature during an interventional radiology procedure to treat hypervascularized tumours and arteriovenous malformation in a variety of anatomies (e.g., head, neck, spine, liver, genitourinary tract, uterus, gastrointestinal, limbs and lungs); it does not include a pharmaceutical agent. It is typically available as injectable solution containing numerous microspheres [e.g., compressible polyvinyl alcohol (PVA) microspheres] intended to permanently obstruct blood flow to the tumour/malformation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Regulatory Flags#

DUNS number
635091932
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884450089194EmboCath® Plus008844500891942017-05-11
00884450089200EmboCath® Plus008844500892002017-05-11
00884450402948Embosphere®00884450402948S020GH/C2019-10-31
00884450403051Embosphere®00884450403051S1010GH/C2019-12-02
00884450403136Embosphere®00884450403136S1020GH/C2019-09-10
00884450403150Embosphere®00884450403150S120GH/C2019-03-25
00884450403174Embosphere®00884450403174S210GH/C2019-03-13
00884450403402Embosphere®00884450403402S410GH/C2019-03-29
00884450403426Embosphere®00884450403426S420GH/C2019-06-17
00884450403433Embosphere®00884450403433S610GH/C2019-03-29
00884450403440Embosphere®00884450403440S620GH/C2019-03-08
00884450403457Embosphere®00884450403457S810GH/C2019-04-09
00884450403464Embosphere®00884450403464S820GH/C2019-03-08
00884450403716Embosphere®00884450403716V220GH/B2022-10-01
00884450403822Embosphere®00884450403822V610GH/B2022-10-01
00884450306208EmboCube®Initial ReleaseEC25502026-01-15
00884450306215EmboCube®Initial ReleaseEC251002026-01-15
00884450306239EmboCube®Initial ReleaseEC50502026-01-15
00884450306246EmboCube®Initial ReleaseEC501002026-01-15
00884450408810Torpedo™Initial ReleaseTOR25102026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150044177Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044184Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044191Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00199150044207Concerto Versa™MEDTRONIC, INC.KRD2026-10-18
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.HCG2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.HCG2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.HCG2026-10-01