Creagh Medical

FDA Filings

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

FDA Registration(s)

• Registration Number: 3005994106
• FEI Number: 3005994106
• Name: Shawn Fuller
• Owner & Operator: Creagh Medical
• Contact Address: IDA Business Park, Ballinasloe; Co. Galway IE-G Galway N/A IE
• US Agent:
  • Shawn Fuller
  • Surmodics
  • 952 5007090
  • sfuller@surmodics.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9924 West 74th Street ; Eden Prairie, MN 55344 US
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K180007 | LIT Shawn Fuller [Creagh Medical]	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	2018-07-03
PMN K180007 | DQY Shawn Fuller [Creagh Medical]	018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter	2018-07-03
PMN K173560 | DQY Shawn Fuller [Creagh Medical]	Telemark Microcatheter	2018-05-02
PMN K172567 | MJN Shawn Fuller [Creagh Medical]	GORE Molding and Occlusion Balloon (MOB) Catheter	2018-02-13
PMN K171251 | LIT Shawn Fuller [Creagh Medical]	Advance Serenity 14	2018-01-09
PMN K171251 | LIT Shawn Fuller [Creagh Medical]	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2018-01-09
PMN K171251 Creagh Medical	014 Hydrophilic Coated PTA Balloon Dilatation Catheter	2017-09-08
PMN K170635 | LIT Shawn Fuller [Creagh Medical]	Chameleon PTA Balloon Catheter	2017-08-17
PMN K170635 | KRA Shawn Fuller [Creagh Medical]	Chameleon PTA Balloon Catheter	2017-08-17
PMN K143561 | LIT Shawn Fuller [Creagh Medical]	ELM PTA Balloon Dilatation Catheter	2015-05-21
PMN K143561 | LIT Shawn Fuller [Creagh Medical]	Dynamis PTA Balloon Dilatation Catheter	2015-05-21
PMN K113468 | LIT Shawn Fuller [Creagh Medical]	Passeo-35 HP PTA Balloon Dilatation Catheter	2012-01-05
PMN K113468 | LIT Shawn Fuller [Creagh Medical]	ELM PTA BALLOON DILATATION CATHETER	2012-01-05
PMN K113468 | LIT Shawn Fuller [Creagh Medical]	Dynamis PTA Balloon Dilatation Catheter	2012-01-05
PMN K113468 | DQY Shawn Fuller [Creagh Medical]	Passeo-35 HP PTA Balloon Dilatation Catheter	2012-01-05
PMN K113468 | DQY Shawn Fuller [Creagh Medical]	ELM PTA BALLOON DILATATION CATHETER	2012-01-05
PMN K113468 | DQY Shawn Fuller [Creagh Medical]	Dynamis PTA Balloon Dilatation Catheter	2012-01-05
PMN K102645 | LIT Shawn Fuller [Creagh Medical]	Tersus-14 BTK PTA Balloon Dilatation Catheter	2010-12-17
PMN K102645 | LIT Shawn Fuller [Creagh Medical]	Passeo-35 HP Balloon Dilatation Catheter	2010-12-17
PMN K102645 | LIT Shawn Fuller [Creagh Medical]	ELM PTA Balloon Dilatation Catheter	2010-12-17
PMN K102645 | LIT Shawn Fuller [Creagh Medical]	Dynamis PTA Balloon Dilatation Catheter	2010-12-17
PMN K102645 | DQY Shawn Fuller [Creagh Medical]	Tersus-14 BTK PTA Balloon Dilatation Catheter	2010-12-17
PMN K102645 | DQY Shawn Fuller [Creagh Medical]	Passeo-35 HP Balloon Dilatation Catheter	2010-12-17
PMN K102645 | DQY Shawn Fuller [Creagh Medical]	ELM PTA Balloon Dilatation Catheter	2010-12-17
PMN K102645 | DQY Shawn Fuller [Creagh Medical]	Dynamis PTA Balloon Dilatation Catheter	2010-12-17
PMN K082646 | DQY Shawn Fuller [Creagh Medical]	OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER	2010-06-10
PMN K072156 | DQY Shawn Fuller [Creagh Medical]	OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER	2007-11-20

Similar & Related FDA Registered Companies

• Creagh Medical Ltd. (a Wholly Owned Subsidiary Of Surmodics,
• Creagh Medical Ltd.