R4 Vascular, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “R4 Vascular, Inc.” (first 2007, latest 2013), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 88 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 | 1 | 37 |
| 2013 | 1 | 29 |
| 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 3 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 | 2 |
| MSD | Catheter, Hemodialysis, Implanted | 2 | 2 |
Review panels
Most recent R4 Vascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131329 | VECTOR PTA BALLOON DILATATION CATHETER | LIT | 2013-06-06 | 29 |
| K121385 | VECTOR | LIT | 2012-06-14 | 37 |
| K100169 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER | MSD | 2010-02-18 | 29 |
| K091506 | DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 | MSD | 2010-01-08 | 232 |
| K092040 | PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 | LJS | 2009-11-18 | 139 |
| K083763 | ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN | LJS | 2009-03-16 | 88 |
| K071361 | R4 VASCULAR INC. PEGASUS CT PICC, MODEL 500005-001,002, 004, 005, 500004-001, 002,004,005 | LJS | 2007-08-20 | 97 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-05-03.
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 R4 Vascular, Inc.?
FDA lists 7 510(k) clearances under the applicant name “R4 Vascular, Inc.” (first 2007, latest 2013), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by R4 Vascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R4 Vascular, Inc. is 88 days.
Which FDA product codes appear under R4 Vascular, Inc.?
The most frequent FDA product codes under this applicant name are LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 3); LIT (Catheter, Angioplasty, Peripheral, Transluminal, 2); MSD (Catheter, Hemodialysis, Implanted, 2).
Next steps
- See all 7 R4 Vascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LJS, R4 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 (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.