Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Angiotech — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
108 daysmedian FDA review time
1342 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151112 | Quill Polypropylene Knotless Tissue-Closure Device, Variable | Angiotech | 2015-09-10 | 135 | 0 |
| DEN090007 | BIO-SEAL LUNG BIOPSY TRACT SYSTEM | Angiotech | 2012-12-19 | 1342 | 0 |
| K120827 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) | Angiotech | 2012-07-13 | 116 | 0 |
| K113744 | QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIOXANONE) | Angiotech | 2012-02-01 | 43 | 0 |
| K113800 | QUILL QUADRAHELIX TISSUE-CLOSURE DEVICE | Angiotech | 2012-01-20 | 28 | 0 |
| K073672 | SKATER BILIARY CATHETER | Angiotech | 2008-01-24 | 28 | 0 |
| K070610 | SKATER BILIARY CATHETER | Angiotech | 2007-06-21 | 108 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda