Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Guidant Corporation · Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
128 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K060449 | HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE | Guidant Corporation | 2006-05-30 | 98 | 0 |
| K053459 | OMNILINK .035 BILIARY STENT SYSTEM | Guidant Corporation | 2006-04-12 | 120 | 0 |
| K053454 | RX HERCULINK ELITE BILIARY STENT SYSTEM | Guidant Corporation | 2006-03-06 | 87 | 0 |
| K053019 | ACUITY STEERABLE STYLET ACCESSORY | Guidant Corporation | 2006-03-03 | 128 | 0 |
| K052965 | EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. | Guidant Corporation | 2006-02-13 | 115 | 0 |
| K052274 | GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM | Guidant Corporation | 2005-09-21 | 30 | 4 |
| K052166 | MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM | Guidant Corporation | 2005-08-18 | 9 | 0 |
| K052165 | RX ACCUNET EMBOLIC PROTECTION SYSTEM | Guidant Corporation | 2005-08-16 | 7 | 0 |
| K041981 | GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDAN | Guidant Corporation | 2004-08-20 | 28 | 2 |
| K041762 | FINISHING WIRE SUPPORTRAK | Guidant Corporation | 2004-08-06 | 37 | 0 |
| K041574 | CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 | Guidant Corporation | 2004-07-12 | 28 | 0 |
| K031903 | RAPIDO CUT-AWAY BLEEDBACK CONTROL VALVE (BBCV), MODEL 7568 | Guidant Corporation | 2004-03-03 | 257 | 1 |
| K032530 | MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM | Guidant Corporation | 2003-10-23 | 69 | 1 |
| K031688 | RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE | Guidant Corporation | 2003-07-02 | 30 | 1 |
| K031505 | RAPIDO CUT-AWAY GUIDING CATHETER | Guidant Corporation | 2003-06-25 | 42 | 1 |
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