Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DXE — Predicate Candidate Screening
74 FDA 510(k) clearances under this product code; the 50 most recent screened below.
138 daysmedian FDA review time
269 days90th percentile
74clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC | 2024-08-28 | 230 | 0 |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences | 2024-07-02 | 53 | 0 |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences | 2024-05-22 | 173 | 0 |
| K233819 | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC | 2024-05-22 | 173 | 0 |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Cath | Edwards Lifesciences | 2024-05-20 | 189 | 0 |
| K213771 | Merlin Aspiration System | Mivi Neurovascular, Inc. | 2022-01-27 | 56 | 0 |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | 2021-09-07 | 410 | 0 |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Ballo | Edwards Lifesciences, LLC | 2020-06-12 | 190 | 2 |
| K163031 | Bunegin-Albin Air Aspiration Set | Cook Incorporated | 2017-07-27 | 269 | 0 |
| K163353 | Needle's Eye Snare Retrieval Set - 54cm | Cook Incorporated | 2017-07-11 | 223 | 0 |
| K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015-09-18 | 30 | 0 |
| K100840 | EMBO PLUS EMBOLECTOMY CATHETER | Hotspur Technologies | 2010-07-12 | 110 | 0 |
| K100842 | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON | Hotspur Technologies | 2010-07-12 | 109 | 0 |
| K081573 | MEDTRONIC EXPORT AP CATHETER | Medtronic Vascular | 2008-06-27 | 22 | 0 |
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | LeMaitre Vascular, Inc. | 2003-01-14 | 196 | 10 |
| K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BAL | Atrium Medical Corp. | 2002-05-08 | 70 | 0 |
| K011783 | MULTI-SNARE SET | Pfm Produkte Fur Die Medizin AG | 2002-01-24 | 231 | 1 |
| K002627 | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | 2001-04-26 | 246 | 0 |
| K992933 | LEMAITRE IRRIGATION CATHETER | Vascutech, Inc. | 2000-03-08 | 190 | 0 |
| K992934 | LEMAITRE VENOUS THROMBECTOMY CATHETER | Vascutech, Inc. | 2000-03-01 | 183 | 0 |
| K992940 | LEMAITRE BALLOON CATHETER WITH IRRIGATION | Vascutech, Inc. | 2000-02-22 | 175 | 0 |
| K992368 | LEMAITRE EMBOLECTOMY CATHETER | Vascutech, Inc. | 1999-12-09 | 147 | 9 |
| K973477 | BIOSENSORS EMBOLECTOMY CATHETER | Sunscope Intl., Inc. | 1998-09-04 | 354 | 0 |
| K982141 | ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 | Arrow Intl., Inc. | 1998-08-31 | 75 | 0 |
| K971314 | DCAT EMBOLECTOMY CATHETER SYSTEM | AngioDynamics, Inc. | 1998-03-17 | 342 | 0 |
| K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | Microvena Corp. | 1998-03-06 | 246 | 1 |
| K973465 | LATIS GRAFT CLEANING CATHETER | Applied Medical Resources | 1998-02-19 | 160 | 1 |
| K974335 | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LL | J-Lloyd Medical, Inc. | 1998-02-13 | 87 | 0 |
| K972572 | SINGLE LUMEN EMBOLECTOMY CATHETER | American Biomed, Inc. | 1998-01-13 | 187 | 0 |
| K972623 | LMI IRRIGATION CATHETER (IGR) | Lucas Medical, Inc. | 1997-11-19 | 128 | 0 |
| K970657 | LMI THROMBECTOMY CATHETER | Lucas Medical, Inc. | 1997-07-01 | 130 | 0 |
| K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | Applied Medical Resources | 1997-03-28 | 25 | 2 |
| K961883 | VERSA-CATH ARTERIAL CATHETER | Ideas For Medicine, Inc. | 1997-01-13 | 243 | 0 |
| K961992 | NEEDLE'S EYE SNARE | Cook Pacemaker Corp. | 1996-12-27 | 220 | 0 |
| K961716 | VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE | Ideas For Medicine, Inc. | 1996-09-19 | 140 | 0 |
| K954760 | LMI ARTERIAL EMBOLECTOMY CATHETER | Lucas Medical, Inc. | 1996-04-11 | 177 | 0 |
| K955125 | LMI OCCLUSION CATHETER | Lucas Medical, Inc. | 1996-03-11 | 123 | 0 |
| K950586 | AVD INTIMAX THROMBECTOMY CATHETER | Applied Medical Resources | 1995-05-15 | 95 | 0 |
| K935405 | ARTERIAL EMBOLECTOMY | J-Lloyd Medical, Inc. | 1994-07-25 | 258 | 0 |
| K920823 | WELTER SNARE RETRIEVER | Cook, Inc. | 1993-03-04 | 374 | 0 |
| K920871 | J-LLOYD ARTERIAL EMBOLECTOMY CATHETER | J-Lloyd Medical, Inc. | 1993-02-26 | 367 | 0 |
| K914880 | DUAL BALLOON EMBOLECTOMY CATHETER | Ideal Medical, Inc. | 1992-03-16 | 138 | 0 |
| K910372 | INTIMAX THROMBECTOMY CATHETER | Applied Vascular Devices, Inc. | 1991-04-26 | 87 | 1 |
| K905139 | CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER | Cathlab Corp. | 1991-02-25 | 108 | 0 |
| K902327 | EMBOLECTOMY CATHETER | Clincal Instruments Corp. | 1991-02-25 | 277 | 3 |
| K901502 | AMPLATZ GOOSE-NECK SNARE | Microvena Corp. | 1990-12-03 | 249 | 1 |
| K901627 | ARTERIAL EMBOLECTOMY CATHETER | Applied Vascular Devices, Inc. | 1990-10-19 | 193 | 1 |
| K900311 | ARTERIAL EMBOLECTOMY CATHETER | Impra, Inc. | 1990-07-17 | 176 | 0 |
| K901625 | FOGARTY ARTERIAL EMBOLECTOMY II CATHETER | Baxter Healthcare Corp | 1990-07-06 | 88 | 0 |
| K897184 | 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS | Cathlab Corp. | 1990-03-14 | 76 | 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