Bacchus Vascular, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bacchus Vascular, Inc.” (first 2001, latest 2008), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | 7 | 7 |
| MCW | Catheter, Peripheral, Atherectomy | 3 | 3 |
Review panels
- Cardiovascular (10)
Most recent Bacchus Vascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K082199 | SPIRALFUSE PERIPHERAL INFUSION SYSTEM | QEY | 2008-10-17 | 74 |
| K071664 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM | QEY | 2007-07-13 | 25 |
| K050147 | TRELLIS-8 PERIPHERAL INFUSION SYSTEM | QEY | 2005-02-03 | 10 |
| K033997 | SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 | MCW | 2004-02-04 | 42 |
| K032261 | Trellis Reserve Infusion System | QEY | 2003-08-22 | 30 |
| K023514 | TRELLIS-6 PERIPHERAL INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH) | QEY | 2002-12-02 | 42 |
| K022640 | SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM | MCW | 2002-12-02 | 116 |
| K021958 | TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM (100CM CATHETER LENGTH 10CM INFUSION H | QEY | 2002-07-03 | 19 |
| K013635 | TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) | QEY | 2002-02-11 | 98 |
| K003570 | BACCHUS THROMBECTOMY CATHETER (BTC), MODEL BTC-0755 | MCW | 2001-06-06 | 198 |
Recalls
2 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-11-24.
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 Bacchus Vascular, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Bacchus Vascular, Inc.” (first 2001, 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 Bacchus Vascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bacchus Vascular, Inc. is 42 days.
Which FDA product codes appear under Bacchus Vascular, Inc.?
The most frequent FDA product codes under this applicant name are QEY (Mechanical Thrombolysis Catheter, 7); MCW (Catheter, Peripheral, Atherectomy, 3).
Next steps
- See all 10 Bacchus Vascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEY, Bacchus Vascular, Inc.'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.