ShortCut

Primary DI
07290020101242
Brand
ShortCut
Company
PI-CARDIA LTD
Model
Z-A-20.003-US
Device description
Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures.
Published
2024-12-05
Public version status
New
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
SCZPercutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCZPercutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve ProceduresCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240017000ShortCutPi-Cardia, Ltd.2024-09-27SCZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290020101242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290020101242072900201012427290020101242

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac valvuloplasty catheterA sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888) 705-5366customerservice@pi-cardia.net

Regulatory Flags#

DUNS number
532731150
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true