FDA.reportPublic FDA data

Balloon Catheter

Primary DI
00842429103388
Brand
Balloon Catheter
Company
Microvention, Inc.
Model
BC0410C-ID-700
Catalog number
BC0410C
Device description
Scepter C
Published
2022-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous
MJNCatheter, intravascular occluding, temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429103388PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429103388008424291033888424291033880842429103388

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

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
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
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
00810170017933Azur Detachable Helical HydroCoil45-48061045-4806102015-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06934955914713Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914720Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914737Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914744Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914751Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914768Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914775Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914782Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914799Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914805Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914812Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914829Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914836Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914843Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914850Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914867Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914874Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914881Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914898Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914904Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914911Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
06934955914928Teleport Glide MicrocatheterOrbusNeich Medical (ShenZhen) Co., Ltd.DQY2026-07-20
00810024671885CPS Locator 3D, Small Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671892CPS Locator 3D, Medium Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671908CPS Locator 3D, Large Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671915CPS Locator 3D, Medium, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
00810024671922CPS Locator 3D, Large, Extra Long Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-07-13
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALDQY2026-07-08
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