FDA.reportPublic FDA data

GALT MEDICAL CORP.

Matched from indexed company URL: Galt Medical Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16493953000718472GALT MEDICAL CORP.1N2026-01-012220 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 GUDIDProductPhoneEmail
00841268100855Guidewire - SGW-019-38800-639-2800customerservice@galtneedletech.com
00841268100862Guidewire - SGW-019-40800-639-2800customerservice@galtneedletech.com
00841268100879Guidewire - SGW-019-41800-639-2800customerservice@galtneedletech.com
00841268100886Guidewire - SGW-019-52800-639-2800customerservice@galtneedletech.com
00841268100893Guidewire - SGW-019-53800-639-2800customerservice@galtneedletech.com
00841268100909Guidewire - SGW-021-02800-639-2800customerservice@galtneedletech.com
00841268100916Guidewire - SGW-021-03800-639-2800customerservice@galtneedletech.com
00841268100923Guidewire - SGW-021-04800-639-2800customerservice@galtneedletech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
4301590264666K982559GUIDEWIREDQX1999-02-01
4301678251487K192195Sterile DilatorDRE2019-09-26
4301203698071K182660GaltTWSDRB2019-05-30
4301665475832K172487Coaxial Dilator Set (Micro-Introducer)DRE2017-10-16
4301670550218K152528Attachable Cath Lab Hemostasis ValveDTL2015-12-02
4301819268843K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)DQX2015-04-23
4301042780052K140028GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCERDYB2014-08-21
4301127760062K123430MICROSLIDER TEARAWAY INTRODUCER SETDYB2013-04-12
4301926988196K112398TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORTDYB2012-04-12
4301700306330K071330GALTSTICK INTRODUCER SYSTEMDRE2007-10-31
4301465743914K043525CATHETER INTRODUCERDYB2005-02-09
4301857821467K021990GALT MEDICAL GUIDEWIREDQX2002-07-18
4301855815254K000737COAXIAL DILATOR SETDRE2000-08-01
4301108758527K000313TEARAWAY INTRODUCER SHEATHDYB2000-06-16
4301067056713
4301264547627
4301309240122
4301472714485
4301676603404
4301883150328
4301904748360

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB52014-08-21
DRE42019-09-26
DQX32015-04-23
DRB12019-05-30
DTL12015-12-02

PMN#

GaltTWS

2019-05-30

Galt Medical Corp.

GUDID#

200 records. Showing 1-40. Next