FDA.reportPublic FDA data

Halo™ Single Loop Snare Kit

Primary DI
00886333224906
Brand
Halo™ Single Loop Snare Kit
Company
ARGON MEDICAL DEVICES, INC.
Model
383625065
Catalog number
383625065
Device description
Halo™ Single Loop Snare Kit 6F, 25mm x 65cm
Published
2021-01-06
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
MMXDevice, Percutaneous Retrieval

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMXDevice, Percutaneous RetrievalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200268000Halo™ Single-Loop Snare KitArgon Medical Devices, Inc.2020-06-03MMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886333224906PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886333224906008863332249068863332249060886333224906

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter-snareA sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Kit
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
00886333226931Micro-Access Introducer4978374978372026-10-07
00886333226948Micro-Access Introducer4978394978392026-10-07
00886333004171V•Stick™ Vascular Access Set390204400E390204400E2016-09-16
00886333004188V•Stick™ Vascular Access Set391504000E391504000E2016-09-16
00886333004195V•Stick™ Vascular Access Set391504300E391504300E2016-09-16
00886333004201V•Stick™ Vascular Access Set391504400E391504400E2016-09-16
00886333004218V•Stick™ Vascular Access Set391504500E391504500E2016-09-16
00886333004225V•Stick™ Vascular Access Set391505000E391505000E2016-09-16
00886333004232V•Stick™ Vascular Access Set391505300E391505300E2016-09-16
00886333004249V•Stick™ Vascular Access Set391505400E391505400E2016-09-16
00886333004256V•Stick™ Vascular Access Set391505500E391505500E2016-09-16
00886333004263V•Stick™ Vascular Access Set391605300E391605300E2016-09-16
00886333004270V•Stick™ Vascular Access Set391604000E391604000E2016-09-16
00886333004287V•Stick™ Vascular Access Set391604300E391604300E2016-09-16
00886333004294V•Stick™ Vascular Access Set391604400E391604400E2016-09-16
00886333004300V•Stick™ Vascular Access Set391604500E391604500E2016-09-16
00886333004317V•Stick™ Vascular Access Set391605000E391605000E2016-09-16
00886333004324V•Stick™ Vascular Access Set391605400E391605400E2016-09-16
00886333004331V•Stick™ Vascular Access Set391605500E391605500E2016-09-16
00886333007042V•Stick™ Vascular Access Set391705400E391705400E2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00850041730141LimFlow V-CeiverInari Medical, Inc.MMX2024-03-09
20827002132874Gunther TulipCOOK INCORPORATEDMMX2023-12-04
00860008180605ONO Retrieval DeviceOnocor LLCMMX2023-08-04
00850041730004LimFlow V-CeiverInari Medical, Inc.MMX2023-06-26
00884450681732ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
10884450681739ONE Snare®Merit Medical Systems, Inc.MMX2023-04-21
05415067034496Aveir™ST. JUDE MEDICAL, INC.MMX2023-03-03
00884450681749ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
10884450681746ONE Snare®Merit Medical Systems, Inc.MMX2023-02-22
00884450681848ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
10884450681845ONE Snare®Merit Medical Systems, Inc.MMX2023-02-09
00884450681725ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
10884450681722ONE Snare®Merit Medical Systems, Inc.MMX2023-02-01
00884450681718ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
10884450681715ONE Snare®Merit Medical Systems, Inc.MMX2023-01-20
00884450681787ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
10884450681784ONE Snare®Merit Medical Systems, Inc.MMX2023-01-13
00884450681763ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
10884450681760ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
00884450681800ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16
10884450681807ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16