Cardinal Health Australia 503 Pty L T D

FDA Filings

This page includes the latest FDA filings for Cardinal Health Australia 503 Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013552412
• FEI Number: 3013552412
• Name: Cardinal Health Australia 503 PTY LTD
• Owner & Operator: Cardinal Health 200, LLC
• Contact Address: 3651 Birchwood Drive --; Waukegan IL 60085 US
• US Agent:
  • Stacey Henning
  • Cardinal Health
  • 312 2702081
  • stacey.henning@cardinalhealth.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Level 11, 50 Queen Street ; Melbourne Victoria, 3000 AU
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN P120002 | NIP Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System	2017-05-23
PMN P030047 | NIM Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	PRECISE NITINOL STENT SYSTEM	2017-05-23
PMN P020036 | NIO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. and S.M.A.R.T. CONTROL Nitinol Stent System	2017-05-23
PMN P020026 | NIQ Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	CYPHER DRUG-ELUTING STENTS	2017-05-23
PMN K994068 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Nitinol Stent Transhepatic Biliary System	2017-05-23
PMN K993720 | KNQ Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Maxi LD Large Diameter Balloon Dilatation Catheter	2017-05-23
PMN K992825 | LIT Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Powerflex Extreme PTA Balloon Catheter	2017-05-23
PMN K991811 | LIT Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Maxi DS PTA Balloon Catheter	2017-05-23
PMN K981407 | LIT Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Powerflex Plus PTA Balloon Catheter	2017-05-23
PMN K981407 | LIT Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Opta LP PTA Balloon Catheter	2017-05-23
PMN K974560 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	JINDO" Steerable Guidewires	2017-05-23
PMN K963000 | LIT Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Maxi LD PTA Balloon Catheter	2017-05-23
PMN K955728 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Cordis Biliary Stent	2017-05-23
PMN K942094 | LIT Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	SAVVY PTA Balloon Catheter	2017-05-23
PMN K131225 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	ADROIT Guiding Catheter	2017-05-23
PMN K130981 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Re-Flex Biliary Self-Expanding Stent System	2017-05-23
PMN K121125 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.TFlex Biliary Self-Expanding Stent System	2017-05-23
PMN K062531 | NTE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	ANGIOGUARD EMBOLI CAPTURE GUIDEWIRE	2017-05-23
PMN K060877 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz Blue .014 Transhepatic Biliary System	2017-05-23
PMN K040413 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz Blue .018 Transhepatic biliary System	2017-05-23
PMN K034050 | DTK Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Vena Cava Filters	2017-05-23
PMN K021345 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz Genesis Transhepatic Biliary Stent on Slalom.018 Delivery System	2017-05-23
PMN K010445 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Precise RX Nitinol Transhepatic Biliary Stent System	2017-05-23
PMN K003159 | LIT Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Slalom PTA Balloon Catheter	2017-05-23
PMN K003159 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Slalom PTA Balloon Catheter	2017-05-23
PMN K001139 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Preface Guiding Sheath	2017-05-23
PMN K000564 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Medium Palmaz Transhepatic Biliary Stent and Delivery System	2017-05-23
PMN K993091 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz XL Transhepatic Biliary Stent System	2017-05-18
PMN K964688 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz Schatz Balloon Expandable Stent	2017-05-18
PMN K932788 | DWZ Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Bipal 7 Biopsy Forceps	2017-05-18
PMN K920289 | DWZ Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Bipal 7 Biopsy Forceps	2017-05-18
PMN K914567 | DWZ Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Bipal Biopsy Forceps	2017-05-18
PMN K913801 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Cordis Catheter Sheath Introducer System with Unistasis Valve	2017-05-18
PMN K862006 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Stand and HighFlow Femoral Ventricular Pigtail Catheter	2017-05-18
PMN K854576 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Modified PTCA Catheter	2017-05-18
PMN K844161 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	PTCA Guiding Catheter	2017-05-18
PMN K091077 | DTK Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Optease Vena Cava Filter	2017-05-18
PMN K062798 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Smart Stent	2017-05-18
PMN K042969 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Modification to Smart Control	2017-05-18
PMN K032457 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Modification to Smart Control	2017-05-18
PMN K012090 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz Genesis Transhepatic Biliary Stent	2017-05-18
PMN K012087 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz Genesis Transhepatic Biliary Stent	2017-05-18
PMN K010083 | DTK Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Trapease Permanent Vena Cava Filter	2017-05-18
PMN K003964 | DTK Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Trapease Permanent Vena Cava Filter	2017-05-18
PMN K000062 | DTK Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	TRAPEASE Vena Cava Filter and Introduction Kit	2017-05-18
PMN K943340 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Steerable Guidewire	2017-05-17
PMN K925833 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Steerable Guidewire	2017-05-17
PMN K923134 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Steerable Guidewire	2017-05-17
PMN K914863 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	CINCH Steerable Guidewire	2017-05-17
PMN K905423 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	REFLEX Steerable Guidewire	2017-05-17
PMN K902612 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	CINCH Steerable Guidewire	2017-05-17
PMN K894633 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Steerable Coated Guidewire	2017-05-17
PMN K873403 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Steerable Guidewire	2017-05-17
PMN K020809 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Palmaz Genesis Transhepatic Biliary Stent (modification)	2017-05-17
PMN P100013 | MGB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Cordis EXOSEAL Vascular Closure Device	2017-05-16
PMN K982770 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	6F Envoy Guiding Catheter	2017-05-16
PMN K973401 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Tempo Angiography Catheter	2017-05-16
PMN K971646 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Nylex	2017-05-16
PMN K971572 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Vista Brite Tip Catheters	2017-05-16
PMN K965211 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Vista Brite Tip Catheters	2017-05-16
PMN K963962 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Vista Brite Tip Catheters	2017-05-16
PMN K963214 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	ST Steerable Guidewire	2017-05-16
PMN K963171 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	CINCH QR Steerable Guidewire Extension	2017-05-16
PMN K962830 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Vista brite Tip Catheter	2017-05-16
PMN K962765 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Marker Wire Steerable Guidewire (Stabilizer & WIZDOM with Radiopaque Markers)	2017-05-16
PMN K962759 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	4F Nylex	2017-05-16
PMN K962362 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Envoy and Vista Brite Tip Catheter	2017-05-16
PMN K952185 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Vista Brite Tip and Guiding Catheter	2017-05-16
PMN K952067 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Steerable Guidewire	2017-05-16
PMN K950316 | DQX Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Steerable Guidewire	2017-05-16
PMN K933235 | DWE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Biopsy Forceps	2017-05-16
PMN K930479 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Nylex Catheters	2017-05-16
PMN K915836 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	5F Super Torque	2017-05-16
PMN K862975 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	PTCA Guiding Catheters	2017-05-16
PMN K023907 | KNQ Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Maxi LD	2017-05-16
PMN K000579 | DQO Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Tempo Aqua Angiography Catheter	2017-05-16
PMN K993646 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Nitinol Stent Transhepatic Biliary System	2017-05-15
PMN K983023 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Brite Tip Catheter	2017-05-15
PMN K982632 | DQY Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Envoy and Vista Brite Tip	2017-05-15
PMN K980823 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	PRECISE Nitinol Stent Transhepatic Biliary System (modification)	2017-05-15
PMN K974448 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Brite Tip Catheter Sheath	2017-05-15
PMN K971608 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Brite Tip Catheter Sheath Introduce	2017-05-15
PMN K970392 | DRE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Covidien	2017-05-15
PMN K970392 | DRE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	AVANTI+ Catheter Sheath Introducer	2017-05-15
PMN K945616 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Avanti Catheter Sheath Introducer	2017-05-15
PMN K945524 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Cordis Introducing Catheter	2017-05-15
PMN K932733 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Catheter Sheath Introducer	2017-05-15
PMN K914352 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Obturator	2017-05-15
PMN K911794 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Catheter Sheath Introducer Plus with Unistasis Valve	2017-05-15
PMN K861082 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Catheter Sheath Introducer Mid-length Sheath System	2017-05-15
PMN K851947 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	PTCA Guiding Catheters	2017-05-15
PMN K041796 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	PRECISE RX Nitinol Stent Transhepatic Biliary System	2017-05-15
PMN K032137 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	PRECISE RX Nitinol Stent Transhepatic Biliary System	2017-05-15
PMN K031777 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System (modification)	2017-05-15
PMN K031197 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. CONTROL Nitinol Stent Transhepatic biliary System (modification)	2017-05-15
PMN K030409 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Nitinol Stent Endoscopic Biliary System	2017-05-15
PMN K023217 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. CONTROL Stent Transhepatic Biliary System (modification)	2017-05-15
PMN K021898 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Nitinol Stent Transhepatic Biliary System	2017-05-15
PMN K020052 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Nitinol Transheaptic Biliary System	2017-05-15
PMN K012993 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	Cordis Nitinol Stent Delivery System	2017-05-15
PMN K003365 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Nitinol Stent Endoscopic Biliary System	2017-05-15
PMN K003336 | FGE Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	S.M.A.R.T. Nitinol Stent Transhepatic Biliary System (modification)	2017-05-15
PMN K001135 | DYB Cardinal Health Australia 503 PTY LTD [Cardinal Health 200, LLC]	6F and 7F Introducing Catheter (modification)	2017-05-15