FDA.reportPublic FDA data

Balloon Catheter

Primary DI
00842429106563
Brand
Balloon Catheter
Company
Microvention, Inc.
Model
BC0210M-US
Catalog number
BC0210M
Device description
Scepter Mini
Published
2022-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182829000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182829000Scepter Mini Occlusion Balloon CatheterMicroVention, Inc.2019-07-10DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429106563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429106563008424291065638424291065630842429106563

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA non-powered 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 aneurysms, chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design for balloon inflation, introduction over a guidewire, infusion of contrast medium, or delivery of a smaller catheter or embolic agents; some types have graduated markings to assist insertion. This is a single-use device.

Device Sizes#

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

Contacts#

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

Regulatory Flags#

DUNS number
003263105
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
00842429108574BOBBY/SOFIA KitSF6131-B895-USSF6131-B8952025-04-30
00842429113608ISAACINN6150SIM2-3DINN6150SIM2-3D2025-04-30
00842429113615ISAACINN6150SIM3-3DINN6150SIM3-3D2025-04-30
00842429113622ISAACINN6140TIP45INN6140TIP452025-04-30
00842429108444SofiaDA6115ST-GC-ODDA6115ST2024-10-18
00842429108451SofiaDA6125ST-GC-ODDA6125ST2024-10-18
00842429108468SofiaDA6131ST-GC-ODDA6131ST2024-10-18
00842429118092AccessISC5115ST-RAISC5115ST2024-10-18
00842429117705SOFIA 88DA8115ST-DAC-USDA8115ST2023-06-15
00842429101575Sofia EX 5F - 105cm STRISC5105ST-MVIISC5105ST2019-09-25
00842429101582Sofia EX 5F - 115cm STRISC5115ST-MVIISC5115ST2019-09-25
04987350999795Sofia 5F-125cm STRDA5125STDA5125ST2016-09-24
00816777025913Sofia 5F-125cm STRDA5125ST-EDA5125ST2018-08-07
00816777025920Sofia 5F-115cm STRDA5115ST-EDA5115ST2018-08-07
00812636020082Sofia 5F-115cm STRDA5115STDA5115ST2016-09-24
00812636020419Sofia 6F-115cm STRDA6115STDA6115ST2016-09-24
00812636020426Sofia 6F-125cm STRDA6125STDA6125ST2016-09-24
00812636020433Sofia 6F-135cm STRDA6135STDA6135ST2016-09-24
00812636020440Sofia 6F-115cm STRDA6115STDA6115ST2016-09-24
00812636020457Sofia 6F-125cm STRDA6125STDA6125ST2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
10841156108267TRAPLINERTELEFLEX INCORPORATEDDQY2026-08-18
00199150070114NAMEDTRONIC, INC.DQY2026-04-13
00199150070121NAMEDTRONIC, INC.DQY2026-04-13
00199150070138NAMEDTRONIC, INC.DQY2026-04-13
00199150070145NAMEDTRONIC, INC.DQY2026-04-13
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
10841156111878TURNPIKETELEFLEX INCORPORATEDDQY2025-09-09
10841156111250GUIDELINERTELEFLEX INCORPORATEDDQY2025-07-14
00195451000836Shockwave CS Guide CatheterShockwave Medical, Inc.DQY2025-06-02
10801902217773ARROWTELEFLEX INCORPORATEDDQY2024-04-08
10801902217988ARROWTELEFLEX INCORPORATEDDQY2024-03-18
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