Fox Hollow Technologies: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Fox Hollow Technologies” (first 2003, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 129 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 |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 4 | 4 |
| QEZ | Aspiration Thrombectomy Catheter | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Fox Hollow Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071432 | SILVERHAWK-R PERIPHERAL PLAQUE EXCISION SYSTEM FOR SURGICAL USE | MCW | 2008-02-12 | 265 |
| K071826 | THE RINSPIRATOR, MODELS FG09770, FG08776, FG08777, FG08910 | QEZ | 2007-11-09 | 129 |
| K053460 | MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, | MCW | 2006-01-13 | 31 |
| K043553 | SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 | MCW | 2005-02-18 | 53 |
| K024243 | REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406 | MCW | 2003-06-20 | 179 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-06-17.
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 Fox Hollow Technologies?
FDA lists 5 510(k) clearances under the applicant name “Fox Hollow Technologies” (first 2003, latest 2008), 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 Fox Hollow Technologies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fox Hollow Technologies is 129 days.
Which FDA product codes appear under Fox Hollow Technologies?
The most frequent FDA product codes under this applicant name are MCW (Catheter, Peripheral, Atherectomy, 4); QEZ (Aspiration Thrombectomy Catheter, 1).
Next steps
- See all 5 Fox Hollow Technologies clearances with predicates and recalls
- Run predicate analysis for product code MCW, Fox Hollow Technologies'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.