FDA.reportPublic FDA data

Gallant™ PTCA Dilatation Catheter

Primary DI
07290107014526
Brand
Gallant™ PTCA Dilatation Catheter
Company
MEDINOL LTD.
Model
SCG250R30US
Published
2018-08-15
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
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173581000Gallant PTCA Dilatation CatheterMedinol, Ltd.2018-01-25LOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290107014526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290107014526072901070145267290107014526

GMDN Terms#

Term, Definition table
TermDefinition
Coronary angioplasty balloon catheter, basicA flexible tube designed for percutaneous transluminal coronary angioplasty (PTCA) to dilate a stenotic coronary artery by controlled inflation of a distensible balloon(s) at its distal tip. It is typically available as: 1) an over-the-wire (OTW) type that has a double or triple-lumen, one for the guidewire and one or two for single- or double-balloon inflation; and 2) a rapid exchange (RX) type with a single-lumen. It is available in various sizes for the dilatation of small, narrowed, or obstructed coronary arteries or bypass grafts. It may also be intended for pre- or post-dilatation of a balloon-expandable stent (not included) in the coronary arteries. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Outer Diameter2.5Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+972732265727contact@medinol.com

Regulatory Flags#

DUNS number
600593800
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
07290107013529EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R12US2017-12-18
07290107013536EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R15US2017-12-18
07290107013543EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R17US2017-12-18
07290107013550EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R20US2017-12-18
07290107013567EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R24US2017-12-18
07290107013574EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R28US2017-12-18
07290107013581EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN250R33US 2017-12-18
07290107013598EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R08US2017-12-18
07290107013604EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R12US2017-12-18
07290107013611EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R15US 2017-12-18
07290107013628EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R17US2017-12-18
07290107013635EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R20US2017-12-18
07290107013642EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R24US2017-12-18
07290107013659EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R28US2017-12-18
07290107013666EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN275R33US 2017-12-18
07290107013697EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R08US2017-12-18
07290107013703EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R12US2017-12-18
07290107013710EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R15US 2017-12-18
07290107013727EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R17US 2017-12-18
07290107013734EluNIR Ridaforolimus Eluting Coronary Stent SystemLUN300R20US2017-12-18

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Primary DI, Brand, Company table
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