Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medtronic Vascular, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
181 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182957 | Heli-FX EndoAnchor System | Medtronic Vascular, Inc. | 2018-11-21 | 28 | 0 |
| K171866 | Sentrant Introducer Sheath with Hydrophilic Coating | Medtronic Vascular, Inc. | 2017-12-20 | 181 | 0 |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peri | Medtronic Vascular, Inc. | 2017-06-16 | 144 | 0 |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor Cassett | Medtronic Vascular, Inc. | 2017-06-13 | 29 | 0 |
| K161361 | HawkOne Directional Atherectomy System | Medtronic Vascular, Inc. | 2016-10-14 | 151 | 2 |
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