FDA.reportPublic FDA data

Cardiva VASCADE MVP XL VVCS 10-12F

Primary DI
M7298001012XL0
Brand
Cardiva VASCADE MVP XL VVCS 10-12F
Company
CARDIVA MEDICAL, INC.
Model
800-1012XL
Device description
The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F 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 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
Published
2024-05-29
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

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7298001012XL1PackageHIBCC5In Commercial Distribution
M7298001012XL2PackageHIBCC10In Commercial Distribution
M7298001012XL3PackageHIBCC1In Commercial Distribution
M7298001012XL0PrimaryHIBCC0

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
M7298001014XL0VASCADE MVP XL VVCS800-1012XL2026-05-18
M729500580C0Cardiva Catalyst II VCS500-580C2015-12-29
M729600580CP0Cardiva Catalyst III VCS600-580CP2015-12-29
M729500580C2Cardiva Catalyst II VCS500-580C2015-12-29
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
M7298001014XL0VASCADE MVP XL VVCSCARDIVA MEDICAL, INC.MGB2026-05-18
10841156111335MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111359MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111373MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111397MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156103439D-STATTELEFLEX INCORPORATEDMGB2025-07-16
20841156103436D-STATTELEFLEX INCORPORATEDMGB2025-07-16
05391530280617Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280648Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280624Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280655Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280679Celt ACD PLUS Vascular Closure Device 7FVASORUM LIMITEDMGB2025-04-24
10841156109905MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109929MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109936MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109950MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109902MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109926MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109933MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109957MANTATELEFLEX INCORPORATEDMGB2024-09-09
10705032090278MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
20705032090275MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
10841156109080D-STATTELEFLEX INCORPORATEDMGB2023-12-11
20841156109087D-STATTELEFLEX INCORPORATEDMGB2023-12-11
00856279007307MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007321MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007345MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007369MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
10856279007304MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23