VASCADE MVP XL VVCS

Primary DI
M7298001014XL0
Brand
VASCADE MVP XL VVCS
Company
CARDIVA MEDICAL, INC.
Model
800-1012XL
Device description
The VASCADE MVP XL Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable collagen patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10F to 14F (17F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
Published
2026-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGBDevice, Hemostasis, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGBDevice, Hemostasis, VascularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P120016029
P120016039

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P120016029VASCADE VASCULAR CLOSURE SYSTEMCardiva Medical, Inc.2013-01-31MGB
P120016039VASCADE VASCULAR CLOSURE SYSTEMCardiva Medical, Inc.2013-01-31MGB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7298001014XL1PackageHIBCC5In Commercial Distribution
M7298001014XL2PackageHIBCC10In Commercial Distribution
M7298001014XL3PackageHIBCC1In Commercial Distribution
M7298001014XL0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery closure plug/patch, collagenAn implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1-800-537-2802customerserviceNA@haemonetics.com

Regulatory Flags#

DUNS number
128112195
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M729500580C0Cardiva Catalyst II VCS500-580C2015-12-29
M729600580CP0Cardiva Catalyst III VCS600-580CP2015-12-29
M729500580C2Cardiva Catalyst II VCS500-580C2015-12-29
M7298001012XL0Cardiva VASCADE MVP XL VVCS 10-12F800-1012XL2024-05-29
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12F800-1012XL2024-05-29
M729700500DX0Cardiva VASCADE 5F VCS700-500DX2015-12-29
M729700580I0Cardiva VASCADE 6/7F VCS700-580I2015-12-29
M729800612C0Cardiva VASCADE MVP VVCS 6-12F800-612C2018-11-28
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
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10841156111397MANTATELEFLEX INCORPORATEDMGB2025-10-13
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05391530280655Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
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