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.
800-612C
In Commercial Distribution
CARDIVA MEDICAL, INC.
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.
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 |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| MGB | Device, Hemostasis, Vascular |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| P120016 | 024 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 15 and 25 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: Catheter Gauge: 6 to 12 French |
Device Record Status
96eabb31-a160-483e-87d4-4657e4757361
May 13, 2024
7
November 28, 2018
May 13, 2024
7
November 28, 2018
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 |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1-408-470-7170
customerservice@cardivamedical.com +1-408-470-7170
CustomerServiceNA@haemonetics.com
customerservice@cardivamedical.com +1-408-470-7170
CustomerServiceNA@haemonetics.com