FDA.reportPublic FDA data

Control RX-LP Mechanical Thrombectomy System

Primary DI
B090ASP10010
Brand
Control RX-LP Mechanical Thrombectomy System
Company
Zien Medical Technologies, LLC
Model
ASP-1001
Catalog number
ASP-1001
Device description
The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Published
2023-04-26
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

Product Codes#

Code, Name table
CodeName
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEZAspiration Thrombectomy CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131998000ASPIRE RX-LP6 ASPIRATION CATHETERControl Medical Technology, LLC2013-11-26QEZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090ASP10011PackageHIBCC1In Commercial Distribution
B090ASP10012PackageHIBCC9In Commercial Distribution
B090ASP10010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Catheter Length0

Regulatory Flags#

DUNS number
017535668
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
00850068519361SAM MedicalIO845-1P2026-09-03
00850068519378SAM MedicalIO846-1P2026-09-03
00850068519385SAM MedicalIO847-1P2026-09-03
10853624005008PenBlade Safety Scalpel#10 BladePB-M-102020-09-21
10853624005015PenBlade Safety Scalpel#11P BladePB-M-11P2020-09-21
10853624005022PenBlade Safety Scalpel#15 BladePB-M-152020-09-21
B0902P0130B0Knight Microcatheter2P0-130-B2P0-130-B2024-04-30
B0902P0130S0Knight Microcatheter2P0-130-S2P0-130-S2024-04-30
B0905XGW0SPINR5X-GW5X-GW2022-07-21
B090A110600Control 11F Mechanical Thrombectomy System, 60cmA11-060A11-0602022-06-29
B090A110900Control 11F Mechanical Thrombectomy SystemA11-090A11-0902022-06-29
B090A50550Aspire Max 5 Aspiration Catheter 55cmA5-055A5-0552017-08-17
B090A51350Control 5F Mechanical Thrombectomy System 135cmA5-135A5-1352017-08-17
B090A61350Control 6F Mechanical Thrombectomy System 135cmA6-135A6-1352017-08-17
B090A70900Control 7F Mechanical Thrombectomy SystemA7-090A7-0902022-06-29
B090A90600Control 9F Mechanical Thrombectomy System, 60cmA9-060A9-0602022-06-29
B090A90900Control 9F Mechanical Thrombectomy System, 90cmA9-090A9-0902022-06-29
B090ARXLP60Control RX-LP Mechanical Thrombectomy System, 136cmARX-LP6ARX-LP62017-08-17
B090ASP10130Control 7F Mechanical Thrombectomy SystemASP-1013ASP-10132023-05-03
B090ASP10210Control 11F Mechanical Thrombectomy SystemASP-1021ASP-10212023-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00763000998011Liberant™MEDTRONIC, INC.QEZ2026-05-09
10841156110505PRONTOTELEFLEX INCORPORATEDQEZ2026-03-30
00851279008910pVasc Aspiration Catheter 70, 115 cmVesalioQEZ2026-03-26
00851279008927pVasc Aspiration Catheter 70, 125 cmVesalioQEZ2026-03-26
00851279008934pVasc Aspiration Catheter 70, 132 cmVesalioQEZ2026-03-26
00851279008941pVasc Aspiration Catheter 70, 140 cmVesalioQEZ2026-03-26
00860011713104FLOWRUNNER 14F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713111FLOWRUNNER 12F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713128FLOWRUNNER 12F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713142FLOWRUNNER 14F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713166FLOWRUNNER 12F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
00860011713180FLOWRUNNER 14F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
B090P110900VentiV ScientificZien Medical Technologies, LLCQEZ2025-11-24
B090P11090F0VentiV ScientificZien Medical Technologies, LLCQEZ2025-11-24
B090P110901VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F1VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
10841156110482PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
20841156110489PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
10841156110475PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
20841156110472PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
10841156110499PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
20841156110496PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
15051684025966AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025959AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025942AlphaVacAngiodynamics, Inc.QEZ2024-09-27
00813132029869QuickClear Aspiration PumpPhilips Image Guided Therapy CorporationQEZ2023-06-09
B090ASP10130Control 7F Mechanical Thrombectomy SystemZien Medical Technologies, LLCQEZ2023-05-03
B090ASP10210Control 11F Mechanical Thrombectomy SystemZien Medical Technologies, LLCQEZ2023-05-03