Home GUDID B479PCE10000000 PolarCath
Primary DI B479PCE10000000
Brand PolarCath
Company Nucryo Vascular
Model PCE1000000
Device description PolarCath catheter extension for use with PolarCath peripheral dilation system
Published 2018-03-19
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 Product Codes# Code, Name table Code Name DQY Catheter, Percutaneous LIT Catheter, Angioplasty, Peripheral, Transluminal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DQY Catheter, Percutaneous Cardiovascular 2 LIT Catheter, Angioplasty, Peripheral, Transluminal Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B479PCE10000001 Package HIBCC 5 In Commercial Distribution B479PCE10000000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Peripheral angioplasty balloon catheter, basic A 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.
Regulatory Flags# DUNS number 045796615 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07613327623338 AXS Lift Stryker Corporation DQY 2025-03-04 07613327623376 AXS Lift Stryker Corporation DQY 2025-03-04 07613327417203 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327417227 AXS Catalyst 7 Stryker Corporation DQY 2019-05-13 07613327313888 DAC 038 Stryker Corporation DQY 2016-09-21 07613327313901 DAC 057 Stryker Corporation DQY 2016-09-21 07613327313932 DAC 070 Stryker Corporation DQY 2016-09-21 07613327313949 DAC 057 Stryker Corporation DQY 2016-09-21 08033477029573 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029580 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477029603 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029627 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029641 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029665 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029689 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477029702 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029726 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477029733 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477029764 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477029788 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029801 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477029818 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477029825 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477029849 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477035277 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30 08033477035291 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477035307 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477035314 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477035321 PACIFIC XTREME MEDTRONIC, INC. DQY 2016-04-30 08033477035338 PACIFIC XTREME MEDTRONIC, INC. LIT 2016-04-30