FDA.reportPublic FDA data

Chameleon

Primary DI
07290016745061
Brand
Chameleon
Company
AV MEDICAL TECHNOLOGIES LTD
Model
10x40
Catalog number
CH10-40-75US
Device description
Chameleon PTA Balloon Dilatation Catheter 10x40 mm
Published
2017-11-16
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
KRACatheter, Continuous Flush
LITCatheter, Angioplasty, Peripheral, Transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016745061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016745061072900167450617290016745061

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral angioplasty balloon catheter, basicA sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include microsurgical blades (atherotomes) to score the plaque. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-200-0118info@a-vmedical.com

Regulatory Flags#

DUNS number
600459882
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016745016chameleon5x40CH05-40-75US2016-09-24
07290016745023Chameleon6x40CH06-40-75US2016-09-24
07290016745030Chameleon7x40CH07-40-75US2016-09-24
07290016745047Chameleon8x40CH08-40-75US2016-09-24
07290016745054Chameleon9x40CH09-40-75US2017-11-16
07290016745085Chameleon12x40CH12-40-75US2017-11-16

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B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
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00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
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00850291007369InThrill SheathInari Medical, Inc.KRA2023-07-18
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix AXInari Medical, Inc.KRA2023-04-24
00850291007222Protrieve SheathInari Medical, Inc.KRA2023-03-20
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
10193489069334NAMICMEDLINE INDUSTRIES, INC.LIT2021-10-28