Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DRA — Predicate Candidate Screening
42 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
194 days90th percentile
42clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262165 | FARADRIVE™ Steerable Sheath (M004PF21M402) | Boston Scientific Corporation | 2026-07-24 | 28 | 0 |
| K250529 | Globe Introducer (601-01001) | Kardium, Inc. | 2025-06-03 | 99 | 0 |
| K233248 | FARADRIVE™ Steerable Sheath | Boston Scientific Corporation | 2023-12-11 | 74 | 3 |
| K232321 | FlexCath Contour™ Steerable Sheath | Medtronic, Inc. | 2023-10-31 | 89 | 0 |
| K223824 | POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARM | Boston Scientific Corporation | 2023-03-22 | 91 | 1 |
| K221397 | MitraClip G4 Steerable Guide Catheter | ABBOTT MEDICAL | 2022-09-28 | 138 | 0 |
| K221044 | AcQGuide® VUE Steerable Sheath | Acutus Medical, Inc. | 2022-05-05 | 27 | 0 |
| K211100 | AcQGuide MAX Steerable Sheath | Acutus Medical, Inc. | 2021-05-14 | 31 | 0 |
| K202620 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2020-11-13 | 64 | 0 |
| K192422 | Steerable Introducer 12F | Freudenberg Medical, LLC | 2019-10-04 | 30 | 0 |
| K190167 | MitraClip G4 Steerable Guide Catheter | Abbott | 2019-05-29 | 118 | 0 |
| K183174 | FlexCath Advance Steerable Sheath and Dilator | Medtronic Cryocath, LP | 2018-11-26 | 10 | 0 |
| K172394 | Steerable Guide Catheter | Abbott Vascular | 2017-09-06 | 29 | 0 |
| K162925 | AcQGuide Steerable Sheath | Acutus Medical, Inc. | 2017-04-06 | 169 | 0 |
| K160919 | Hansen Medical Magellan Robotic Catheter 9Fr | Hansen Medical, Inc. | 2016-09-20 | 169 | 0 |
| K161985 | Steerable Guide Catheter | Abbott Vascular | 2016-08-07 | 19 | 0 |
| K152310 | HeartLight Deflectable Sheath | Cardiofocus, Inc. | 2016-02-24 | 194 | 0 |
| K153304 | Hansen Medical Magellan Robotic Catheter eKit | Hansen Medical, Inc. | 2016-02-01 | 77 | 0 |
| K151463 | Hansen Medical Magellan Robotic Catheter 6Fr and Accessory C | Hansen Medical, Inc. | 2015-08-18 | 78 | 0 |
| K133552 | MAGELLAN ROBOTIC CATHETER 6FR (GUIDE AND LEADER), MAGELLAN R | Hansen Medical | 2014-02-07 | 80 | 0 |
| K123591 | FLEXCATH ADVANCE STEERABLE SHEATH (12 FRENCH) | Medtronic Cryocath, LP | 2012-12-27 | 36 | 0 |
| K122275 | ARTISAN EXTEND CONTROL CATHETER | Hansen Medical | 2012-08-29 | 30 | 0 |
| K120086 | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUT | Cardiosolutions | 2012-04-24 | 104 | 0 |
| K112541 | Z FLEX-270TM STEERABLE SHEATH | Great Batch Medical | 2012-02-07 | 159 | 1 |
| K112239 | STEERABLE GUIDE CATHETER | Abbott Vascular | 2011-08-31 | 27 | 0 |
| K102176 | FLEXCATH STEERABLE SHEATH (12 FRENCH), FLEXCATH STEERABLE SH | Medtronic Cryocath, LP | 2010-09-01 | 29 | 1 |
| K100789 | MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2010-04-21 | 30 | 0 |
| K093866 | EVALVE STEERABLE GUIDE CATHETER | Evalve, Inc. | 2010-01-13 | 27 | 0 |
| K091596 | EVALVE STEERABLE GUIDE CATHETER, MODEL SGC01ST | Evalve, Inc. | 2009-07-02 | 30 | 0 |
| K083793 | STEERABLE GUIDE CATHETER | Evalve, Inc. | 2009-04-27 | 126 | 0 |
| K081049 | FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12 | Cryocath Technologies, Inc. | 2008-06-27 | 74 | 0 |
| K070357 | FLEXCATH STEERABLE SHEATH & DILATOR | Cryocath Technologies, Inc. | 2007-12-28 | 324 | 0 |
| K052575 | LUMINARY CANNULATOR BIDEFLECTABLE CATHETER WITH LUMEN | St Jude Medical | 2006-01-19 | 122 | 0 |
| K050472 | LYSUS INFUSION SYSTEM | Ekos Corp. | 2005-03-11 | 15 | 0 |
| K040165 | REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WI | St Jude Medical | 2004-05-12 | 107 | 0 |
| K012143 | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LIN | Medtronic Cardiac Surgical Products | 2001-10-24 | 106 | 0 |
| K924227 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1993-06-29 | 312 | 0 |
| K913940 | RESPONSE(TM) STEERABLE CATHETER | Daig Corp. | 1993-01-26 | 511 | 0 |
| K904785 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1991-03-06 | 135 | 0 |
| K900320 | CRI CYNOSAR CATHETER | Catheter Research C/O Burditt, Bowles & Radzius | 1990-09-14 | 234 | 0 |
| K884337 | MICRO-GUIDE SYSTEM | Catheter Research C/O Burditt, Bowles & Radzius | 1989-01-05 | 83 | 0 |
| K834352 | ADULT VENT CATHETER | Dlp, Inc. | 1984-01-27 | 45 | 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