FDA.reportPublic FDA data

PROWLER

Primary DI
10886704085584
Brand
PROWLER
Company
Medos International Sàrl
Model
MC1755S2U
Catalog number
MC1755S2U
Device description
PROWLER SELECT LP ES microcatheter
Published
2022-05-24
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
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K214025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K214025000PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL2022-04-12KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704085584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670408558410886704085584

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
DM exempt
true
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
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28
10705034643397VELYS4516110614516110612025-03-28
10705034643403VELYS4516110224516110222025-03-28
10705034643410VELYS4516110234516110232025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0086001552775287 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-08-06
0086001552776987 NeuGlide CatheterPIRAEUS MEDICAL INC.QJP2026-08-06
00850074235132Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-07-31
05391539370173Millipede88 Access CatheterPERFUZE LIMITEDQJP2026-07-15
008537990079308F Base Camp System 2.0 90cmROUTE 92 MEDICALQJP2026-07-08
04547327166140SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166157SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166164SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166171SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166188SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166195SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166201SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166218SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166225SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166232SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166249SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
04547327166256SAYA 86ASAHI INTECC CO., LTD.QJP2026-06-12
0086001552770787 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
0086001552771487 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-05-18
00850014025397APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025403APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025410APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
00850014025427APRO 45 Intermediate CatheterAlembic, LLCQJP2026-03-25
05391539370197Millipede 088 Access CatheterPERFUZE LIMITEDQJP2026-03-24
00850074235101Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-16
0086001030636987 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
0086001030637687 NeuGlide+ CatheterPIRAEUS MEDICAL INC.QJP2026-02-02
00860013060619Toro 88 Superbore CatheterToro Neurovascular, Inc.QJP2026-02-02
00812212030764Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24
00812212030771Zoom 4S CatheterIMPERATIVE CARE, INC.QJP2025-11-24