FDA.reportPublic FDA data

HydroPearl

Primary DI
00816777026088
Brand
HydroPearl
Company
Microvention, Inc.
Model
HP2S0075
Catalog number
HP2S0075
Device description
Bland Beads
Published
2018-08-07
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
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
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
K150870000
K192684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150870000HydroPearl Microspheres, HydroPearl MicrospheresMicroVention, Inc.2015-12-21KRD
K192684000HydroPearl MicrospheresMicroVention, Inc.2020-01-22NOY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816777026088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816777026088008167770260888167770260880816777026088

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
00810170012112V-Grip Detachment ControllerVG501VG5012016-09-24
00810170012129Azur Detachment Controller45-400145-40012016-09-24
00810170012136Azur Pushable Helical45-28020245-2802022015-12-29
00810170012143Azur Pushable Helical45-28030245-2803022015-12-29
00810170012150Azur Pushable Helical45-28030445-2803042015-12-29
00810170012167Azur Pushable Helical45-28040245-2804022015-12-29
00810170012174Azur Pushable Helical45-28040445-2804042015-12-29
00810170012181Azur Pushable Helical45-28040645-2804062015-12-29
00810170012198Azur Pushable Helical45-28050445-2805042015-12-29
00810170012204Azur Pushable Helical45-28050645-2805062015-12-29
00810170012211Azur Pushable Helical45-28051045-2805102015-12-29
00810170012228Azur Pushable Helical45-28060645-2806062015-12-29
00810170012235Azur Pushable Helical45-28061045-2806102015-12-29
00810170012242Azur Pushable Helical45-28061445-2806142015-12-29
00810170012259Azur Pushable Helical45-28081045-2808102015-12-29
00810170012266Azur Pushable Helical45-28081445-2808142015-12-29
00810170012273Azur Pushable Helical45-28101445-2810142015-12-29
00810170012440Azur Pushable Helical45-25040445-2504042015-12-29
00810170012457Azur Pushable Helical45-25040645-2504062015-12-29
00810170012464Azur Pushable Helical45-25050445-2505042015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000495619Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
00763000495640Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.KRD2023-08-07
07613327578577Target TetraStryker CorporationKRD2022-12-19
07613327578591Target TetraStryker CorporationKRD2022-12-19
07613327578607Target TetraStryker CorporationKRD2022-12-19
07613327578638Target TetraStryker CorporationKRD2022-12-19
07613327578676Target TetraStryker CorporationKRD2022-12-19
07613327578683Target TetraStryker CorporationKRD2022-12-19
07613327578690Target TetraStryker CorporationKRD2022-12-19
07613327578706Target TetraStryker CorporationKRD2022-12-19
07613327578737Target TetraStryker CorporationKRD2022-12-19
07613327578744Target TetraStryker CorporationKRD2022-12-19
07613327580099Target TetraStryker CorporationKRD2022-12-19
00763000488673Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488703Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000488949Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489182Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489250Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489281Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
00763000489328Axium™ Detachable Coil SystemMicro Therapeutics, Inc.KRD2022-10-28
07613327466386TARGETStryker CorporationKRD2019-09-05
07613327466416TARGETStryker CorporationKRD2019-09-05
07613327466423TARGETStryker CorporationKRD2019-09-05
00847536033085AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033122AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033146AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033221AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033382AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033405AxiumTMMicro Therapeutics, Inc.KRD2019-06-29
00847536033429AxiumTMMicro Therapeutics, Inc.KRD2019-06-29