FDA.reportPublic FDA data

Agile Angler

Primary DI
G544AMD147
Brand
Agile Angler
Company
Agile Devices, Inc.
Model
ADM-147
Catalog number
ADM-147
Device description
Agile Angler 147cm 3F Steerable Deflectable Microcatheter, Sterile
Published
2023-10-23
Public version status
New
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
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211110000Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.2022-01-07KRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G544AMD147PrimaryHIBCC0

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
Length130Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
6172062089ben@agiledevices.com

Regulatory Flags#

DUNS number
079588524
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
G544ADM18130Agile AnglerADM18-130ADM18-1302026-01-30
G544ADM18147Agile AnglerADM18-147ADM18-1472026-01-30
G544ADM21130Agile AnglerADM21-130ADM21-1302023-10-23
G544ADM21147Agile AnglerADM21-147ADM21-1472023-10-23
G544ADM130Agile AnglerADM- 130ADM-1302023-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.KRA2026-05-28
G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023825Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
07640132622690M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
10351688505620MedexICU MEDICAL, INC.KRA2016-12-29
10351688506856MedexICU MEDICAL, INC.KRA2016-10-12
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08714729280613Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
08714729280620Renegade™ HI-FLO™BOSTON SCIENTIFIC CORPORATIONKRA2016-09-24
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