Galt Medical Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Galt Medical Corp.” (first 1999, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 63 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 237 |
| 2013 | 1 | 156 |
| 2014 | 1 | 227 |
| 2015 | 1 | 90 |
| 2016 | 1 | 209 |
| 2017 | 2 | 63 |
| 2018 | 0 | — |
| 2019 | 2 | 146 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Galt Medical Corp. took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYB | Introducer, Catheter | 6 | 6 |
| DQX | Wire, Guide, Catheter | 4 | 4 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 3 | 3 |
| DRB | Stylet, Catheter | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (15)
Most recent Galt Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K192195 | Sterile Dilator | DRE | 2019-09-26 | 44 |
| K182660 | GaltTWS | DRB | 2019-05-30 | 247 |
| K173287 | Elite HV Radial | DYB | 2017-12-21 | 66 |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | DRE | 2017-10-16 | 60 |
| K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | DYB | 2016-07-05 | 209 |
| K152528 | Attachable Cath Lab Hemostasis Valve | DTL | 2015-12-02 | 90 |
| K140028 | GALT VTI LOW INSERTION VALVE TEARAWAY INTRODUCER | DYB | 2014-08-21 | 227 |
| K123430 | MICROSLIDER TEARAWAY INTRODUCER SET | DYB | 2013-04-12 | 156 |
| K112398 | TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT | DYB | 2012-04-12 | 237 |
| K071330 | GALTSTICK INTRODUCER SYSTEM | DRE | 2007-10-31 | 173 |
5 earlier clearances. See the full list in Caduvo.
Recalls
22 product recalls in 7 recall events; 10 initiated in the last five years. Most recent: 2026-06-26.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Galt Medical Corp.?
FDA lists 15 510(k) clearances under the applicant name “Galt Medical Corp.” (first 1999, latest 2019), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Galt Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Galt Medical Corp. is 90 days. Since 2017: 63 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Galt Medical Corp.?
The most frequent FDA product codes under this applicant name are DYB (Introducer, Catheter, 6); DQX (Wire, Guide, Catheter, 4); DRE (Dilator, Vessel, For Percutaneous Catheterization, 3).
Next steps
- See all 15 Galt Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code DYB, Galt Medical Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.