Creagh Medical, Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Creagh Medical, Ltd.” (first 2010, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 73 days. Since 2017 the median was 82 days, against 96 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 133 |
| 2018 | 1 | 107 |
| 2019 | 0 | — |
| 2020 | 1 | 58 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 57 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Creagh Medical, Ltd. took a median 82 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Creagh Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230191 | Arise UHP Dilatation Catheter | LIT | 2023-03-22 | 57 |
| K200700 | Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter | LIT | 2020-05-14 | 58 |
| K180007 | 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter | LIT | 2018-04-19 | 107 |
| K171251 | 014 Hydrophilic Coated PTA Balloon Dilatation Catheter | LIT | 2017-09-08 | 133 |
| K113468 | ELM PTA BALLON DILATATION CATHETER | LIT | 2011-12-20 | 28 |
| K102645 | WILLOW/ELM PTA BALLOON DILATATION CATHETER | LIT | 2010-12-10 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Creagh Medical, Ltd..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, (1 510(k)s)
- Creagh Medical Ltd. Dba Surmodics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Creagh Medical, Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Creagh Medical, Ltd.” (first 2010, latest 2023), across 1 product code 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 Creagh Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Creagh Medical, Ltd. is 73 days. Since 2017: 82 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Creagh Medical, Ltd.?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 6).
Next steps
- See all 6 Creagh Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LIT, Creagh Medical, Ltd.'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.