DEVICE: Cardiva VASCADE MVP VVCS 6-12F (M729800612C0)

Device Identifier (DI) Information

Cardiva VASCADE MVP VVCS 6-12F
800-612C
In Commercial Distribution

CARDIVA MEDICAL, INC.
M729800612C0
HIBCC

1
128112195 *Terms of Use
The VASCADE MVP 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 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60710 Femoral artery closure plug/patch, collagen
An 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MGB Device, Hemostasis, Vascular
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P120016 024
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Catheter Gauge: 6 to 12 French
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Device Record Status

96eabb31-a160-483e-87d4-4657e4757361
May 13, 2024
7
November 28, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
M729800612C2 10 M729800612C0 In Commercial Distribution
M729800612C1 5 M729800612C0 In Commercial Distribution
M729800612C3 1 M729800612C0 In Commercial Distribution 1-pk carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1-408-470-7170
customerservice@cardivamedical.com
+1-408-470-7170
CustomerServiceNA@haemonetics.com
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