All'InCath 035M PTA Balloon Dilatation Catheter ALP035-80-10x20

GUDID 03701261100269

All'InCath 035M PTA Balloon Dilatation Catheter

NEXSTEP MEDICAL

Peripheral angioplasty balloon catheter, basic
Primary Device ID03701261100269
NIH Device Record Keyf9cd8e2a-0962-4f50-b6d1-5c5a43b17dc1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll'InCath 035M PTA Balloon Dilatation Catheter
Version Model Number1
Catalog NumberALP035-80-10x20
Company DUNS266039102
Company NameNEXSTEP MEDICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com
Phone9999999999
Emailinfo@nexstepmedical.com

Device Dimensions

Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere
Catheter Working Length80 Centimeter
Balloon Diameter10 Millimeter
Balloon Length20 Millimeter
Balloon Rated Burst Pressure14 Atmosphere
Introducer Sheath Compatibilit7 French
Guidewire Compatibility0.035 French
Pressure1100 Pound per Square Inch
Balloon Nominal (Inflation) Pr10 Atmosphere

Device Identifiers

Device Issuing AgencyDevice ID
GS103701261100269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-20
Device Publish Date2025-06-12