VASCADE VASCULAR CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Premarket Approval P120016

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the vascade¿ vascular closure system (vcs). This device is indicated for femoral arterial access site closure while reducing times to hemostasis and ambulation in patients who haveundergone diagnostic or interventional endovascular procedures using a 5f, 6f, or 7f procedural sheath. The vascade vcs is also indicated to reduce time to discharge eligibility in patients who have undergone diagnostic endovascular procedures using a 5f, 6f, or 7f procedural sheath.

DeviceVASCADE VASCULAR CLOSURE SYSTEM
Classification NameDevice, Hemostasis, Vascular
Generic NameDevice, Hemostasis, Vascular
ApplicantCARDIVA MEDICAL, INC.
Date Received2012-08-03
Decision Date2013-01-31
Notice Date2013-05-17
PMAP120016
SupplementS
Product CodeMGB
Docket Number13M-0592
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address CARDIVA MEDICAL, INC. 2900 Lakeside Drive suite 160 santa Clara, CA 95054
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P120016Original Filing
S030 2022-10-11 30-day Notice
S029
S028 2021-02-08 Normal 180 Day Track
S027 2019-07-08 Normal 180 Day Track
S026 2018-11-23 Normal 180 Day Track No User Fee
S025 2018-07-10 Real-time Process
S024 2018-05-30 Panel Track
S023 2017-03-20 30-day Notice
S022 2017-01-17 30-day Notice
S021 2016-11-04 Normal 180 Day Track
S020 2016-06-03 Real-time Process
S019 2016-01-07 30-day Notice
S018 2015-11-16 30-day Notice
S017 2015-11-03 135 Review Track For 30-day Notice
S016 2015-06-29 Special (immediate Track)
S015 2015-05-18 Real-time Process
S014 2015-04-03 Normal 180 Day Track No User Fee
S013 2015-03-12 30-day Notice
S012 2015-03-03 30-day Notice
S011 2015-02-25 30-day Notice
S010 2015-02-18 30-day Notice
S009 2015-02-09 30-day Notice
S008 2014-12-12 30-day Notice
S007 2014-10-20 30-day Notice
S006 2014-09-29 30-day Notice
S005 2014-08-18 135 Review Track For 30-day Notice
S004 2014-08-18 Real-time Process
S003 2014-06-27 30-day Notice
S002 2014-03-31 Real-time Process
S001 2014-03-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
M729700580I1 P120016 000
M729700500DX1 P120016 000
M729800612C2 P120016 024
M7298001012XL2 P120016 029

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