FDA.reportPublic FDA data

Pounce Venous Thrombectomy System

Primary DI
00812339030319
Brand
Pounce Venous Thrombectomy System
Company
Surmodics, Inc.
Model
VTS-0018-09010
Device description
Pounce Venous Thrombectomy System
Published
2023-10-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812339030319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812339030319008123390303198123390303190812339030319

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy rotational catheterA sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) causing acute vascular obstruction in native and stented blood vessels, or in native and synthetic bypass or haemodialysis access grafts, through a mechanical rotational action intended to erode and aspirate the obstruction for removal. It typically consists of a rotational catheter body/head powered by a magnetic power transmission provided by a connected control unit; ancillary device such as catheter guidewires, sterile cable covers, and collecting bags may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0
Device Size Text, specify0

Regulatory Flags#

DUNS number
098414659
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
false
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
00812339030807Pounce ™ XL ThrombectomyPTS-1011-7F1352024-11-13
00812339030760Pounce ™ LP ThrombectomyPTS-0407-7F1502024-03-19
00812339030784Pounce ™ ThrombectomyPTS-0607-7F1352023-08-16
00812339030302Pounce™ Venous Thrombectomy SystemVTS-1018-090102022-06-22
00812339030326Pounce ™ ThrombectomyPTS-0607-7F1352024-10-18
00812339030814Pounce SheathPFS-0035-16F142026-01-26
00812339030753Pounce SheathPFS-0035-12F142023-09-21
00812339030555Sublime Microcatheter, 014, 65cm, StraightSRA-MC14-STR0652023-04-14
00812339030562Sublime Microcatheter, 014, 65cm, AngleSRA-MC14-ANG0652023-04-14
00812339030579Sublime Microcatheter, 014, 150cm, StraightSRA-MC14-STR1502023-04-14
00812339030586Sublime Microcatheter, 014, 150cm, AngleSRA-MC14-ANG1502023-04-14
00812339030593Sublime Microcatheter, 014, 200cm, StraightSRA-MC14-STR2002023-04-14
00812339030609Sublime Microcatheter, 014, 200cm, AngleSRA-MC14-ANG2002023-04-14
00812339030616Sublime Microcatheter, 018, 65cm, StraightSRA-MC18-STR0652023-04-14
00812339030623Sublime Microcatheter, 018, 65cm, AngleSRA-MC18-ANG0652023-04-14
00812339030630Sublime Microcatheter, 018, 150cm, StraightSRA-MC18-STR1502023-04-14
00812339030647Sublime Microcatheter, 018, 150cm, AngleSRA-MC18-ANG1502023-04-14
00812339030654Sublime Microcatheter, 018, 200cm, StraightSRA-MC18-STR2002023-04-14
00812339030661Sublime Microcatheter, 018, 200cm, AngleSRA-MC18-ANG2002023-04-14
00812339030678Sublime Microcatheter, 035, 90cm, StraightSRA-MC35-STR0902023-04-14

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
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
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
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00810123710126InThrill Thrombectomy CatheterInari Medical, Inc.QEW2025-05-30
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.QEW2025-04-09
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.QEW2024-12-20
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00810123710140ClotTriever CatheterInari Medical, Inc.QEW2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.QEW2024-03-27
00812339030760Pounce ™ LP ThrombectomySurmodics, Inc.QEW2024-03-19
00810123710058ClotTriever SheathInari Medical, Inc.QEW2023-12-15