GALT MEDICAL CORP.

Matched from indexed company URL: GALT MEDICAL

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1649395	3000718472	GALT MEDICAL CORP.	1	N	2026-01-01	2220 Merritt Dr GARLAND TX US 75041

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00841268106963	Micro-Introducer Set - INT-112-06	800-639-2800	customersrvice@galtneedletech.com
00841268108653	Transitionless Radial Access Introducer - CLI-227-07	800-639-2800	customerservice@galtneedletech.com
00841268108660	Transitionless Radial Access Introducer - CLI-227-45	800-639-2800	customerservice@galtneedletech.com
00841268108677	Transitionless Radial Access Introducer - CLI-227-55	800-639-2800	customerservice@galtneedletech.com
00841268108745	Micro-Access Elite HV Introducer Set - CLI-101-25	800-639-2800	customerservice@galtneedletech.com
00841268108752	Micro-Access Elite HV Introducer Set - CLI-101-26	800-639-2800	customerservice@galtneedletech.com
00841268108776	Micro-Access Elite HV Catheter Introducer Set - CLI-112-00	800-639-2800	customerservice@galtneedletech.com
00841268108837	Guidewire - SGW-064-67	800-639-2800	customerservice@galtneedletech.com

galtneedletech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
430	1590264666	K982559	GUIDEWIRE	DQX	1999-02-01
430	1678251487	K192195	Sterile Dilator	DRE	2019-09-26
430	1203698071	K182660	GaltTWS	DRB	2019-05-30
430	1665475832	K172487	Coaxial Dilator Set (Micro-Introducer)	DRE	2017-10-16
430	1670550218	K152528	Attachable Cath Lab Hemostasis Valve	DTL	2015-12-02
430	1819268843	K143252	Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)	DQX	2015-04-23
430	1042780052	K140028	GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER	DYB	2014-08-21
430	1127760062	K123430	MICROSLIDER TEARAWAY INTRODUCER SET	DYB	2013-04-12
430	1926988196	K112398	TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT	DYB	2012-04-12
430	1700306330	K071330	GALTSTICK INTRODUCER SYSTEM	DRE	2007-10-31
430	1465743914	K043525	CATHETER INTRODUCER	DYB	2005-02-09
430	1857821467	K021990	GALT MEDICAL GUIDEWIRE	DQX	2002-07-18
430	1855815254	K000737	COAXIAL DILATOR SET	DRE	2000-08-01
430	1108758527	K000313	TEARAWAY INTRODUCER SHEATH	DYB	2000-06-16
430	1067056713
430	1264547627
430	1309240122
430	1472714485
430	1676603404
430	1883150328
430	1904748360

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DYB	5	2014-08-21
DRE	4	2019-09-26
DQX	3	2015-04-23
DRB	1	2019-05-30
DTL	1	2015-12-02

PMN#

Sterile Dilator

2019-09-26

Galt Medical Corp.

GaltTWS

2019-05-30

Galt Medical Corp.

Elite HV Radial

2017-12-21

Galt Medical Corp.

Coaxial Dilator Set (Micro-Introducer)

2017-10-16

Galt Medical Corp.

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

2016-07-05

GALT MEDICAL CORP.

Attachable Cath Lab Hemostasis Valve

2015-12-02

GALT MEDICAL CORP.

GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER

2014-08-21

GALT MEDICAL CORP.

MICROSLIDER TEARAWAY INTRODUCER SET

2013-04-12

GALT MEDICAL CORP.

TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT

2012-04-12

GALT MEDICAL

GALTSTICK INTRODUCER SYSTEM

2007-10-31

GALT MEDICAL CORP.

CATHETER INTRODUCER

2005-02-09

GALT MEDICAL CORP.

EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE

2003-12-05

GALT MEDICAL CORP.

GALT MEDICAL GUIDEWIRE

2003-07-17

GALT MEDICAL CORP.

GALT MEDICAL GUIDEWIRE

2002-07-18

GALT MEDICAL CORP.

GUIDEWIRE

1999-02-01

GALT MEDICAL CORP.

GUDID#

Micro-Introducer Set - INT-112-06

GALT MEDICAL CORP.

2017-08-09

Guidewire - SGW-064-67

GALT MEDICAL CORP.

2019-05-23

Micro-Access Elite HV Catheter Introducer Set - CLI-112-00

GALT MEDICAL CORP.

2019-05-28

Micro-Access Elite HV Introducer Set - CLI-101-26

GALT MEDICAL CORP.

2019-05-23

Micro-Access Elite HV Introducer Set - CLI-101-25

GALT MEDICAL CORP.

2019-05-23

Transitionless Radial Access Introducer - CLI-227-55

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-227-45

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-227-07

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-227-06

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-226-55

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-226-45

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-226-07

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-226-06

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-225-55

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-225-45

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-225-07

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-225-06

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-134-55

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-134-45

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-134-07

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-134-06

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-133-55

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-133-45

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-133-07

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-133-06

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-132-55

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-132-45

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-132-07

GALT MEDICAL CORP.

2019-05-28

Transitionless Radial Access Introducer - CLI-132-06

GALT MEDICAL CORP.

2019-05-28

MicroIntroducer 3Fr x 7cm ELITE HV - CLI-136-00

GALT MEDICAL CORP.

2019-05-23

Guidewire - SGW-004-06

GALT MEDICAL CORP.

2019-05-23

Posi-Stick® Guidewire - SGW-068-00

GALT MEDICAL CORP.

2019-01-18

Guidewire - SGW-067-01

GALT MEDICAL CORP.

2018-05-23

Guidewire - SGW-060-12

GALT MEDICAL CORP.

2018-05-23

Guidewire - SGW-060-11

GALT MEDICAL CORP.

2018-05-23

Guidewire - SGW-060-10

GALT MEDICAL CORP.

2018-05-23

Guidewire - SGW-060-09

GALT MEDICAL CORP.

2018-05-23

Guidewire - SGW-060-08

GALT MEDICAL CORP.

2018-05-23

Guidewire - SGW-060-07

GALT MEDICAL CORP.

2018-05-23

Guidewire - SGW-060-06

GALT MEDICAL CORP.

2018-05-23

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