FDA.reportPublic FDA data

QuadraSphere Q2™

Primary DI
10884450299491
Brand
QuadraSphere Q2™
Company
BIOSPHERE MEDICAL
Model
00884450299494
Catalog number
V125QS/A
Published
2017-12-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172372000QuadraSphere MicrospheresBiosphere Medical, S.A.2017-09-06KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450299491PackageGS11In Commercial Distribution
00884450299494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445029949110884450299491
00884450299494008844502994948844502994940884450299494

GMDN Terms#

Term, Definition table
TermDefinition
Embolization particle, non-bioabsorbableA sterile, 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
635091932
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884450403204Embosphere®00884450403204S220GH/C2019-03-25
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
00884450408834Torpedo™Initial ReleaseTOR25202026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327635096InZone ISTStryker CorporationKRD2026-07-08
00840303714521Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714538Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714545Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714552Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714569Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714576Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714583Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714590Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714606Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714613Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714620Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714637Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714644Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714651Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714668Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714675Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714682Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00840303714699Optima Coil System (OptiOne Coil System)BALT USA LLCKRD2026-07-06
00763000495626Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28