Home GUDID M729500580C2 Cardiva Catalyst II VCS
Primary DI M729500580C2
Brand Cardiva Catalyst II VCS
Company CARDIVA MEDICAL, INC.
Model 500-580C
Device description The Cardiva Catalyst™ II consists of a sterile disposable Catalyst II Wire and a sterile disposable Catalyst Clip. The Cardiva Catalyst II System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Cardiva Catalyst II is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5F, 6F or 7F introducer sheaths.
Published 2015-12-29
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DXC Clamp, Vascular
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DXC Clamp, Vascular Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M729500580C2 Package HIBCC 10 Not in Commercial Distribution M729500580C0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Femoral artery medicated closure set A collection of hand-operated instruments, which includes a pharmaceutical agent, intended for the percutaneous closure of a femoral artery or vein puncture site, following a catheterization procedure, in patients using an anticoagulant medication (e.g., heparin). The collection typically consists of a catheter/sheath which elutes the pharmaceutical agent, intended to locally reverse the effect of the anticoagulant, and a haemostatic plug intended to be temporarily placed within the artery; implantable devices are not included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Gauge 5 French Catheter Gauge 6 French Catheter Gauge 7 French
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 128112195 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810220800348 Adler Instrument Company Adler, Inc. DXC 2026-06-02 10197344138890 NAMIC MEDLINE INDUSTRIES, INC. DXC 2026-03-16 08022057015884 DeTACH Aortic Cross Clamp Head-Large CORCYM SRL DXC 2026-02-03 08022057015907 DeTACH Aortic Cross Clamp Head-Small CORCYM SRL DXC 2026-02-03 10193489727173 Medline Industries, Inc. MEDLINE INDUSTRIES, INC. DXC 2022-08-04 10195594150808 CARDINAL HEALTH Cardinal Health 200, LLC DXC 2021-07-09 20884521152134 Covidien Cardinal Health, Inc. DXC 2016-09-24 M20630300 D-Stat® Clamp topical hemostat accessory Vascular Solutions, Inc. DXC 2016-09-15 M20635240 Vasc Band™ hemostat Vascular Solutions, Inc. DXC 2016-09-05 M20635270 Vasc Band™ hemostat Vascular Solutions, Inc. DXC 2016-09-05 M20635290 Vasc Band™ hemostat Vascular Solutions, Inc. DXC 2016-09-05 M20635370 Vasc Band™ hemostat Vascular Solutions, Inc. DXC 2016-09-05 10381780142935 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780142942 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780142959 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780142966 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780142973 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780142980 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780142997 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143000 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143017 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143024 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143031 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143048 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143055 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143062 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143079 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143086 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143093 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14 10381780143109 Integra® Jarit® INTEGRA LIFESCIENCES PRODUCTION CORPORATION DXC 2016-08-14
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