ClearStream Technologies , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “ClearStream Technologies , Ltd.” (first 2008, latest 2011), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 5 | 5 |
| DQY | Catheter, Percutaneous | 2 | 2 |
Review panels
- Cardiovascular (7)
Most recent ClearStream Technologies , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112335 | BANTAM CATHETER (280MM BALLOON LENGTHS) | DQY | 2011-10-12 | 61 |
| K102035 | SLEEK OTW PTA CATHETERS | LIT | 2010-12-01 | 135 |
| K101361 | REEFLEX PTA CATHETER | LIT | 2010-08-04 | 82 |
| K100490 | LITEPAC, MODEL 682 | LIT | 2010-03-16 | 25 |
| K093139 | BANTAM,48XXXXXX, 50XXXXXX | LIT | 2009-12-30 | 86 |
| K083596 | REEKROSS FAMILY OR OTW PTA CATHETERS | DQY | 2009-03-02 | 87 |
| K072947 | SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS | LIT | 2008-02-08 | 113 |
Recalls
openFDA lists no recalls under a recalling firm named ClearStream 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 ClearStream Technologies , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “ClearStream Technologies , Ltd.” (first 2008, latest 2011), across 2 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 ClearStream Technologies , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name ClearStream Technologies , Ltd. is 86 days.
Which FDA product codes appear under ClearStream Technologies , Ltd.?
The most frequent FDA product codes under this applicant name are LIT (Catheter, Angioplasty, Peripheral, Transluminal, 5); DQY (Catheter, Percutaneous, 2).
Next steps
- See all 7 ClearStream Technologies , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LIT, ClearStream 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, 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.