FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardiva VASCADE MVP XL VVCS 10-12F
DI: M7298001012XL0
·
Model: 800-1012XL
·
CARDIVA MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Cardiva VASCADE MVP XL VVCS 10-12F
- Primary DI
- M7298001012XL0
- Version / Model
- 800-1012XL
- Company Name
- CARDIVA MEDICAL, INC.
- Labeler DUNS
- 128112195
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-29
- Public Version
- 1
- Public Version Date
- 2024-06-06
- Public Version Status
- New
- Public Device Record Key
- 1fc1d316-5093-4b87-ae5c-76929286ea11
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M7298001012XL2 | HIBCC | 10-pk | 10 | In Commercial Distribution | |
| Primary | M7298001012XL0 | HIBCC | ||||
| Package | M7298001012XL1 | HIBCC | 5-pk | 5 | In Commercial Distribution | |
| Package | M7298001012XL3 | HIBCC | 1-pk | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- +1-800-537-2802
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P120016 | 029 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Catheter Gauge: 10 to 12 French |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius