Cardiva Medical Inc

FDA Filings

This page includes the latest FDA filings for Cardiva Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Cardiva Medical Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Cardiva Medical, Inc.

FDA Registration(s)

• Registration Number: 3011469355
• FEI Number: 3011469355
• Name: Cardiva Medical, Inc.
• Owner & Operator: CARDIVA MEDICAL, INC.
• Contact Address: 1615 Wyatt Dr Suite 160; Santa Clara CA 95054 US
• US Agent:
  • Terry Passarotti Alverson
  • Cardiva Medical, Inc
  • 408 4707119
  • TERRY_PASSAROTTI@CARDIVAMEDICAL.COM
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Carretera Internacional Km. 129, Salida Norte de Guaymas Parque Industrial Rocafuerte; Guaymas Sonora, 85340 MX
• Establishment Type: Manufacture Medical Device

• Registration Number: 3015145497
• FEI Number: 3015145497
• Name: Cardiva Medical, Inc.
• Owner & Operator: CARDIVA MEDICAL, INC.
• Contact Address: 1615 Wyatt Dr Suite 160; Santa Clara CA 95054 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1615 Wyatt Drive ; Santa Clara, CA 95054 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMA P120016S028 CARDIVA MEDICAL, INC.	VASCADE MVP VVCS	2021-08-06
GUDID M729800612C2 CARDIVA MEDICAL, INC.	Cardiva VASCADE MVP VVCS 6-12F	2021-02-05
GUDID M729700580I1 CARDIVA MEDICAL, INC.	Cardiva VASCADE 6/7F VCS	2021-02-05
GUDID M729700500DX1 CARDIVA MEDICAL, INC.	Cardiva VASCADE 5F VCS	2021-02-05
PMA P120016S027 CARDIVA MEDICAL, INC.	Vascade MVP VVCS	2019-09-18
PMA P120016S026 CARDIVA MEDICAL, INC.	Cardiva VASCADE Vascular Closure System (VCS)	2019-02-05
PMA P120016S024 CARDIVA MEDICAL, INC.	VASCADE MVP Venous Vascular Closure System (VVCS)	2018-11-27
PMA P120016S025 CARDIVA MEDICAL, INC.	Cardiva VASCADE VCS	2018-10-02
PMA P120016S021 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM (VCS)	2018-03-30
PMN P080029 | MGB Cardiva Medical, Inc.	Quick-Close Vascular Suturing System	2017-12-28
PMA P120016S023 CARDIVA MEDICAL, INC.	VASCADE 6/7f VCS & VASCADE 5F VCS	2017-04-11
PMA P120016S022 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2017-02-15
PMA P120016S020 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2016-08-01
PMA P120016S017 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2016-03-24
PMA P120016S019 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2016-02-10
PMA P120016S018 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-12-14
PMA P120016S014 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM (VCS)	2015-09-30
PMA P120016S016 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-07-29
PMA P120016S015 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM (VCS)	2015-07-08
PMA P120016S013 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-04-09
PMA P120016S012 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-03-31
PMA P120016S011 CARDIVA MEDICAL, INC.	VASCADE CLOSURE SYSTEM	2015-03-26
PMA P120016S010 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-03-20
PMA P120016S009 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-03-11
PMA P120016S005 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-01-12
PMA P120016S008 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2015-01-09
PMN K130124 | DXC Cardiva Medical, Inc.	Cardiva Catalyst III	2014-12-29
PMN K130124 | DXC Cardiva Medical, Inc.	Cardiva Catalyst III	2014-12-29
PMN K130124 | DXC Cardiva Medical, Inc.	Cardiva Catalyst II	2014-12-29
PMN K130124 | DXC Cardiva Medical, Inc.	Cardiva Catalyst II	2014-12-29
PMN K130124 | DXC Cardiva Medical, Inc.	Cardiva Catalyst II and III	2014-12-29
PMN K130124 | DXC Cardiva Medical, Inc.	Cardiva Catalyst II and III	2014-12-29
PMA P080029S002 Cardiva Medical, Inc.	QUICK-CLOSE VASCULAR SUTURING SYSTEM	2014-12-18
PMA P120016S007 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2014-11-17
PMA P120016S004 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2014-11-06
PMA P120016S006 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2014-10-23
PMA P120016S002 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2014-10-07
PMA P120016S003 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2014-08-07
PMA P120016S001 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2014-04-30
PMN P120016 | MGB Cardiva Medical, Inc.	VASCADE MVP VVCS 6-12F	2013-04-15
PMN P120016 | MGB Cardiva Medical, Inc.	VASCADE MVP VVCS 6-12F	2013-04-15
PMN P120016 | MGB Cardiva Medical, Inc.	VASCADE 6/7F VCS	2013-04-15
PMN P120016 | MGB Cardiva Medical, Inc.	VASCADE 6/7F VCS	2013-04-15
PMN P120016 | MGB Cardiva Medical, Inc.	VASCADE 5F VCS	2013-04-15
PMN P120016 | MGB Cardiva Medical, Inc.	VASCADE 5F VCS	2013-04-15
PMN K130124 CARDIVA MEDICAL, INC.	CATALYST II AND III	2013-03-14
PMA P120016 CARDIVA MEDICAL, INC.	VASCADE VASCULAR CLOSURE SYSTEM	2013-01-31
PMA P080029S001 Cardiva Medical, Inc.	QUICK-CLOSE VASCULAR SUTURING SYSTEM	2011-03-11
PMA P080029 Cardiva Medical, Inc.	QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)	2010-04-08
PMN K082930 CARDIVA MEDICAL, INC.	CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE	2009-02-13
PMN K072297 CARDIVA MEDICAL, INC.	BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM	2007-09-12
PMN K070485 CARDIVA MEDICAL, INC.	BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L	2007-03-22
PMN K051817 CARDIVA MEDICAL, INC.	BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM	2006-12-06
PMN K061075 CARDIVA MEDICAL, INC.	BOOMERANG WIRE	2006-09-01
PMN K041486 CARDIVA MEDICAL, INC.	VASOSTASIS VASCULAR CLOSURE SYSTEM	2004-10-22

Similar & Related FDA Registered Companies

• CARDIVA MEDICAL, INC.2900 Lakeside Drivesuite 160santa Clara, CA 95054 PMA NumberP120016 Supplement NumberS030 Date Received10/11/2022 Decision Date11/08/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	48DM0	CARDIVA MEDICAL, INC.
CAGE Code	48DM0	CARDIVA MEDICAL, INC.
S.A.M. Registration	48DM0 [128112195]	CARDIVA MEDICAL, INC.
SEC	0001520325	Cardiva Medical, Inc. of DELAWARE