Laminate Medical Technologies , Ltd.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Laminate Medical Technologies , Ltd.” (first 2024, latest 2024), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 31 days. 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 |
|---|---|---|
| 2024 | 1 | 31 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Laminate Medical Technologies , Ltd. took a median 31 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 31 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QVQ | Extravascular Support For An Arteriovenous Fistula For Vascular Access | 2 | 1 |
Review panels
- Cardiovascular (2)
Most recent Laminate Medical Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240119 | VasQ | QVQ | 2024-02-16 | 31 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220026 | De Novo | Extravascular Support For An Arteriovenous Fistula For Vascular Access | 2023-09-26 |
Recalls
openFDA lists no recalls under a recalling firm named Laminate Medical Technologies , 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Laminate Medical Technologies , Ltd.?
FDA lists 1 510(k) clearance under the applicant name “Laminate Medical Technologies , Ltd.” (first 2024, latest 2024), plus 1 De Novo decision, 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 Laminate Medical Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laminate Medical Technologies , Ltd. is 31 days.
Which FDA product codes appear under Laminate Medical Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are QVQ (Extravascular Support For An Arteriovenous Fistula For Vascular Access, 2).
Next steps
- See all 1 Laminate Medical Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code QVQ, Laminate Medical Technologies , 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.