Vascular Architects, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Vascular Architects, Inc.” (first 2001, latest 2003), across 3 product codes in 3 review panels. 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 |
|---|---|---|---|
| JCT | Prosthesis, Tracheal, Expandable | 3 | 3 |
| DWX | Stripper, Artery, Intraluminal | 1 | 1 |
| ESW | Prosthesis, Esophageal | 1 | 1 |
Review panels
Most recent Vascular Architects, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K031641 | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM | JCT | 2003-08-01 | 66 |
| K030567 | MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSION DELIVERY SYSTEM | JCT | 2003-03-24 | 28 |
| K012544 | VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM | JCT | 2001-11-15 | 100 |
| K003173 | ASPIRE COVERED STENT AND DELIVERY CATHETER | ESW | 2001-03-13 | 154 |
| K003719 | VASCULAR ARCHITECTS PERISCOPE DEVICE | DWX | 2001-02-28 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Vascular Architects, Inc..
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.
- Vascular Solutions, Inc. (115 510(k)s)
- Vascular Technology Incorporated (11 510(k)s)
- Vascular Control Systems, Inc. (9 510(k)s)
- Vascular Medcure, Inc. (5 510(k)s)
- Vascular Pathways, Inc. (4 510(k)s)
- Vascular Flow Technologies, Ltd. (3 510(k)s)
- Vascular Products, Inc. (3 510(k)s)
- Vascular Graft Solutions, Ltd. (2 510(k)s)
- Vascular Insights, LLC (2 510(k)s)
- Vascular Designs, Inc. (1 510(k)s)
- Vascular Flow Technologies Limited (1 510(k)s)
- Vascular Intervention (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vascular Architects, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Vascular Architects, Inc.” (first 2001, latest 2003), 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 Vascular Architects, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vascular Architects, Inc. is 86 days.
Which FDA product codes appear under Vascular Architects, Inc.?
The most frequent FDA product codes under this applicant name are JCT (Prosthesis, Tracheal, Expandable, 3); DWX (Stripper, Artery, Intraluminal, 1); ESW (Prosthesis, Esophageal, 1).
Next steps
- See all 5 Vascular Architects, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JCT, Vascular Architects, 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.