FDA.reportPublic FDA data

HydroPearl

Primary DI
00812636020655
Brand
HydroPearl
Company
Microvention, Inc.
Model
8HP2S800
Catalog number
8HP2S800
Device description
Bland Beads
Published
2018-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NAJAgents, embolic, for treatment of uterine fibroids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAJAgents, Embolic, For Treatment Of Uterine FibroidsCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150870000HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc.2015-12-21KRD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812636020655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812636020655008126360206558126360206550812636020655

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

Contacts#

Phone, Email table
PhoneEmail
+1(714)247-8000customerservice@microvention.com

Regulatory Flags#

DUNS number
003263105
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842429118788WEB Detachment ControllerWDC-2-MVI-ALWDC-22026-07-30
00842429118689MV Flow Aspiration PumpMVFLOWPMP01-USMVFLOWPMP012026-07-15
00842429118795AZUR Detachment Controller45-4001-AL45-40012025-09-01
00816777020116V-Grip Detachment ControllerVG900VG5012025-08-28
00840273201991AZUR Detachment Controller45-4001-0245-40012025-08-28
00840273202028V-Grip Detachment ControllerVG900-MDRVG5012025-08-28
00842429106464V-Grip Detachment ControllerVG900-ISVG5012025-08-28
00810170018831ERIC Retrieval DeviceER173020-USERIC1730202022-10-12
00810170018848ERIC Retrieval DeviceER174030-USERIC1740302022-10-12
00810170018862ERIC Retrieval DeviceER176044-USERIC1760442022-10-12
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
00812636020471Azur Detachable Helical HydroCoil45-48050545-4805052015-12-29
00812636020488Azur Detachable Helical HydroCoil45-48051045-4805102015-12-29
00812636020495Azur Detachable Helical HydroCoil45-48051545-4805152015-12-29
00812636020501Azur Detachable Helical HydroCoil45-48052045-4805202015-12-29
00810170017841Azur Detachable Helical HydroCoil45-48020245-4802022015-12-29
00810170017858Azur Detachable Helical HydroCoil45-48020445-4802042015-12-29
00810170017865Azur Detachable Helical HydroCoil45-48030245-4803022015-12-29
00810170017902Azur Detachable Helical HydroCoil45-48041045-4804102015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810563021073Embozene Color Advance 75um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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00810563021097Embozene Color Advance 250um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021103Embozene Color Advance 400um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021110Embozene Color Advance 500um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021127Embozene Color Advance 700um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021134Embozene Color Advance 900um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021141Embozene Color Advance 1100um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021158Embozene Color Advance 1300um Embozene 2mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
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00810563021431ONCOZENE 40um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021448ONCOZENE 75um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021455ONCOZENE 75um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021462ONCOZENE 100um Oncozene 2mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021479ONCOZENE 100um Oncozene 3mL - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021486Embozene Color Advance 40um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021493Embozene Color Advance 75um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021509Embozene Color Advance 100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021516Embozene Color Advance 250um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021523Embozene Color Advance 400um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021530Embozene Color Advance 500um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021547Embozene Color Advance 700um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021554Embozene Color Advance 900um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021561Embozene Color Advance 1100um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00810563021578Embozene Color Advance 1300um Embozene 1mL Colored - USVarian Medical Systems, Inc.NAJ2023-05-19
00884450403716Embosphere®BIOSPHERE MEDICALNAJ2022-10-01
00884450403822Embosphere®BIOSPHERE MEDICALNAJ2022-10-01
00884450299432Embosphere®BIOSPHERE MEDICALNAJ2022-09-20
10884450299439Embosphere®BIOSPHERE MEDICALNAJ2022-09-20