Angiotech: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Angiotech” (first 2007, latest 2015), plus 1 De Novo decision, across 4 product codes in 3 review panels. Median 510(k) review time under this name: 76 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 | 3 | 43 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 135 |
| 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 2 | 2 |
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | 2 | 2 |
| NEW | Suture, Surgical, Absorbable, Polydioxanone | 2 | 2 |
| OMT | Absorbable Lung Biopsy Plug | 1 | 0 |
Review panels
Most recent Angiotech 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable Loop Design | GAW | 2015-09-10 | 135 |
| K120827 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) | NEW | 2012-07-13 | 116 |
| K113744 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) | NEW | 2012-02-01 | 43 |
| K113800 | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE | GAW | 2012-01-20 | 28 |
| K073672 | SKATER BILIARY CATHETER | FGE | 2008-01-24 | 28 |
| K070610 | SKATER BILIARY CATHETER | FGE | 2007-06-21 | 108 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN090007 | De Novo | Absorbable Lung Biopsy Plug | 2012-12-19 |
Recalls
openFDA lists no recalls under a recalling firm named Angiotech.
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.
- Angiotech Pharmaceuticals, Inc. (1 510(k)s)
- Angiotech Medical Device Technologies (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Angiotech?
FDA lists 6 510(k) clearances under the applicant name “Angiotech” (first 2007, latest 2015), plus 1 De Novo decision, across 4 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 Angiotech?
The median time from FDA receipt to decision across 510(k)s cleared under the name Angiotech is 76 days.
Which FDA product codes appear under Angiotech?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 2); GAW (Suture, Nonabsorbable, Synthetic, Polypropylene, 2); NEW (Suture, Surgical, Absorbable, Polydioxanone, 2).
Next steps
- See all 6 Angiotech clearances with predicates and recalls
- Run predicate analysis for product code FGE, Angiotech'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.