FDA.reportPublic FDA data

Cardiva Catalyst II VCS

Primary DI
M729500580C0
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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M729500580C2PackageHIBCC10Not in Commercial Distribution
M729500580C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery medicated closure setA 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
TypeValueUnit
Catheter Gauge5French
Catheter Gauge6French
Catheter Gauge7French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1-408-470-7170customerservice@cardivamedical.com

Regulatory Flags#

DUNS number
128112195
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M729700500DX0Cardiva VASCADE 5F VCS700-500DX2015-12-29
M729700580I0Cardiva VASCADE 6/7F VCS700-580I2015-12-29
M7298001012XL0Cardiva VASCADE MVP XL VVCS 10-12F800-1012XL2024-05-29
M7298001014XL0VASCADE MVP XL VVCS800-1012XL2026-05-18
M729800612C0Cardiva VASCADE MVP VVCS 6-12F800-612C2018-11-28
M729600580CP0Cardiva Catalyst III VCS600-580CP2015-12-29
M729500580C2Cardiva Catalyst II VCS500-580C2015-12-29
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12F800-1012XL2024-05-29
M729700500DX1Cardiva VASCADE 5F VCS700-500DX2015-12-29
M729700580I1Cardiva VASCADE 6/7F VCS700-580I2015-12-29
M729800612C2Cardiva VASCADE MVP VVCS 6-12F800-612C2018-11-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436636MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436643MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436681MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776437763MillenniumAvalign Technologies, Inc.DXC2026-10-20
00190776435226MillenniumAvalign Technologies, Inc.DXC2026-10-19
00190776436230MillenniumAvalign Technologies, Inc.DXC2026-10-08
00190776436247MillenniumAvalign Technologies, Inc.DXC2026-10-08
M68931200070CrOCSafeguard US Operating, LLCDXC2026-10-08
00190776434267MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434335MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434366MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434373MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776433314MillenniumAvalign Technologies, Inc.DXC2026-10-05
00810220800577Adler Instrument CompanyAdler, Inc.DXC2026-09-30
00846159036411SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00846159036428SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00190776424107MillenniumAvalign Technologies, Inc.DXC2026-08-27
00190776423889MillenniumAvalign Technologies, Inc.DXC2026-08-26
00190776420345MillenniumAvalign Technologies, Inc.DXC2026-08-25
00190776419080MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776419127MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776417154MillenniumAvalign Technologies, Inc.DXC2026-08-19
00190776411527MillenniumAvalign Technologies, Inc.DXC2026-08-07
00190776408633MillenniumAvalign Technologies, Inc.DXC2026-08-03
00190776422318MillenniumAvalign Technologies, Inc.DXC2026-07-31
00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30