Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Galt Medical Corp. · Predicate Candidate Screening

14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time

227 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K192195	Sterile Dilator	Galt Medical Corp.	2019-09-26	44	0
K182660	GaltTWS	Galt Medical Corp.	2019-05-30	247	0
K173287	Elite HV Radial	Galt Medical Corp.	2017-12-21	66	0
K172487	Coaxial Dilator Set (Micro-Introducer)	Galt Medical Corp.	2017-10-16	60	0
K153533	Tearaway Introducer Sheath, MicroSlide Tearaway Introducer	Galt Medical Corp.	2016-07-05	209	2
K152528	Attachable Cath Lab Hemostasis Valve	Galt Medical Corp.	2015-12-02	90	0
K140028	GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER	Galt Medical Corp.	2014-08-21	227	0
K123430	MICROSLIDER TEARAWAY INTRODUCER SET	Galt Medical Corp.	2013-04-12	156	0
K071330	GALTSTICK INTRODUCER SYSTEM	Galt Medical Corp.	2007-10-31	173	0
K043525	CATHETER INTRODUCER	Galt Medical Corp.	2005-02-09	50	1
K033542	EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE	Galt Medical Corp.	2003-12-05	25	0
K031916	GALT MEDICAL GUIDEWIRE	Galt Medical Corp.	2003-07-17	27	1
K021990	GALT MEDICAL GUIDEWIRE	Galt Medical Corp.	2002-07-18	30	1
K982559	GUIDEWIRE	Galt Medical Corp.	1999-02-01	193	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda