FDA.reportPublic FDA data

PG PRO

Primary DI
00842429106228
Brand
PG PRO
Company
Microvention, Inc.
Model
PGP28165STR
Catalog number
PGP28165STR
Device description
PG PRO
Published
2025-04-30
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
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192625000PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company2019-11-21DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842429106228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842429106228008424291062288424291062280842429106228

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). 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
DM exempt
true
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
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
00860009303423Powered Aventus Clot Management SystemInquis Medical, Inc.KRA2026-10-19
00860009303461C02 Cartridge AccessoryInquis Medical, Inc.KRA2026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmInquis Medical, Inc.KRA2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackInquis Medical, Inc.KRA2026-10-19
00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00840303713104Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
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
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
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