Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cordis Europa, N.V. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
124 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071189 | CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER | Cordis Europa, N.V. | 2007-05-16 | 16 | 0 |
| K063563 | CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BAL | Cordis Europa, N.V. | 2007-03-07 | 99 | 0 |
| K060302 | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED | Cordis Europa, N.V. | 2006-04-11 | 64 | 0 |
| K043605 | INSCOPE 3-STAGE BALLOON DILATOR | Cordis Europa, N.V. | 2005-02-04 | 36 | 0 |
| K040413 | CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 | Cordis Europa, N.V. | 2004-06-21 | 124 | 0 |
| K032737 | CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERF | Cordis Europa, N.V. | 2003-10-02 | 28 | 1 |
| K012056 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM . | Cordis Europa, N.V. | 2001-08-01 | 30 | 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