FDA applicant
Galt Medical Corp.
FDA records 15 decisions for Galt Medical Corp. (Garland, TX) from 1999 to 2019: 15 510(k) clearances. Most are in product codes DYB (Introducer, Catheter) and DQX (Wire, Guide, Catheter). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 17 of them its own earlier devices. 12 recalls are linked to its devices.
FDA’s records also spell it “Galt Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Galt Medical Corp.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2019
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Galt Medical Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report