Novoste Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Novoste Corp.” (first 1988, latest 1995), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 168 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | 3 | 3 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| DYB | Introducer, Catheter | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Novoste Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942977 | NOVOSTE PULSE PLUS BLOOD CONTAINMENT DEVICE | DYB | 1995-12-28 | 556 |
| K911527 | NOVOSTE GUIDING CATHETER | DQY | 1991-04-24 | 20 |
| K900460 | MODIFIED NOVOSTE ANGIOGRAPHIC CATHETER | DQO | 1990-07-17 | 168 |
| K896690 | MODIFIED ANGIOGRAPHIC CATHETER | DQO | 1990-01-24 | 57 |
| K875127 | NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS | DQO | 1988-08-09 | 238 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-01-25.
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.
- Novoste Puerto Rico, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Novoste Corp.?
FDA lists 5 510(k) clearances under the applicant name “Novoste Corp.” (first 1988, latest 1995), across 3 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 Novoste Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novoste Corp. is 168 days.
Which FDA product codes appear under Novoste Corp.?
The most frequent FDA product codes under this applicant name are DQO (Catheter, Intravascular, Diagnostic, 3); DQY (Catheter, Percutaneous, 1); DYB (Introducer, Catheter, 1).
Next steps
- See all 5 Novoste Corp. clearances with predicates and recalls
- Run predicate analysis for product code DQO, Novoste Corp.'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.