FDA Product Code
FDA Product Code DXE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5150
510(k) Clearances — 74 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Edwards Lifesciences, LLC | 2024-08-28 | Traditional | PDF ↗ |
| K241330 | Fogarty Fortis Arterial Embolectomy Catheter | Edwards Lifesciences | 2024-07-02 | Traditional | PDF ↗ |
| K233820 | Fogarty Arterial Embolectomy Catheter with Gate Valve | Edwards Lifesciences | 2024-05-22 | Traditional | PDF ↗ |
| K233819 | Fogarty Venous Thrombectomy Catheters | Edwards Lifesciences, LLC | 2024-05-22 | Traditional | PDF ↗ |
| K233619 | Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters | Edwards Lifesciences | 2024-05-20 | Traditional | PDF ↗ |
| K213771 | Merlin Aspiration System | Mivi Neurovascular, Inc. | 2022-01-27 | Traditional | PDF ↗ |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Applied Medical Resources Corporation | 2021-09-07 | Special | PDF ↗ |
| K193379 | Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe | Edwards Lifesciences, LLC | 2020-06-12 | Traditional | PDF ↗ |
| K163031 | Bunegin-Albin Air Aspiration Set | Cook Incorporated | 2017-07-27 | Traditional | PDF ↗ |
| K163353 | Needle's Eye Snare Retrieval Set - 54cm | Cook Incorporated | 2017-07-11 | Special | PDF ↗ |
| K152335 | Export Advance Aspiration Catheter | Medtronic, Inc. | 2015-09-18 | Special | PDF ↗ |
| K100842 | PTA-PLUS PTA BALLOON CATHER 5 MM X 4CM, PTA-PLUS PTA BALLOON CATHETER 6MM X 4CM | Hotspur Technologies | 2010-07-12 | Traditional | PDF ↗ |
| K100840 | EMBO PLUS EMBOLECTOMY CATHETER | Hotspur Technologies | 2010-07-12 | Traditional | PDF ↗ |
| K081573 | MEDTRONIC EXPORT AP CATHETER | Medtronic Vascular | 2008-06-27 | Special | PDF ↗ |
| K022145 | OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302 | LeMaitre Vascular, Inc. | 2003-01-14 | Traditional | PDF ↗ |
| K020634 | MODIFICATION TO ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | 2002-05-08 | Special | PDF ↗ |
| K011783 | MULTI-SNARE SET | Pfm Produkte Fur Die Medizin AG | 2002-01-24 | Traditional | PDF ↗ |
| K002627 | ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER | Atrium Medical Corp. | 2001-04-26 | Traditional | PDF ↗ |
| K992933 | LEMAITRE IRRIGATION CATHETER | Vascutech, Inc. | 2000-03-08 | Traditional | PDF ↗ |
| K992934 | LEMAITRE VENOUS THROMBECTOMY CATHETER | Vascutech, Inc. | 2000-03-01 | Traditional | PDF ↗ |
| K992940 | LEMAITRE BALLOON CATHETER WITH IRRIGATION | Vascutech, Inc. | 2000-02-22 | Traditional | PDF ↗ |
| K992368 | LEMAITRE EMBOLECTOMY CATHETER | Vascutech, Inc. | 1999-12-09 | Traditional | PDF ↗ |
| K973477 | BIOSENSORS EMBOLECTOMY CATHETER | Sunscope Intl., Inc. | 1998-09-04 | Traditional | PDF ↗ |
| K982141 | ARROW 5FX60CM BALLOON EMBOLECTOMY CATHETER, MODEL # EM-56025 | Arrow Intl., Inc. | 1998-08-31 | Traditional | PDF ↗ |
| K971314 | DCAT EMBOLECTOMY CATHETER SYSTEM | AngioDynamics, Inc. | 1998-03-17 | Traditional | PDF ↗ |
| K972511 | AMPLATZ GOOSE NECK SNARE KIT/ CATHETER | Microvena Corp. | 1998-03-06 | Traditional | PDF ↗ |
| K973465 | LATIS GRAFT CLEANING CATHETER | Applied Medical Resources | 1998-02-19 | Traditional | PDF ↗ |
| K974335 | EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. | J-Lloyd Medical, Inc. | 1998-02-13 | Traditional | PDF ↗ |
| K972572 | SINGLE LUMEN EMBOLECTOMY CATHETER | American Biomed, Inc. | 1998-01-13 | Traditional | PDF ↗ |
| K972623 | LMI IRRIGATION CATHETER (IGR) | Lucas Medical, Inc. | 1997-11-19 | Traditional | PDF ↗ |
| K970657 | LMI THROMBECTOMY CATHETER | Lucas Medical, Inc. | 1997-07-01 | Traditional | PDF ↗ |
| K970762 | DUAL LUMEN EMBOLECTOMY CATHETER | Applied Medical Resources | 1997-03-28 | Traditional | PDF ↗ |
| K961883 | VERSA-CATH ARTERIAL CATHETER | Ideas For Medicine, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K961992 | NEEDLE'S EYE SNARE | Cook Pacemaker Corp. | 1996-12-27 | Traditional | PDF ↗ |
| K961716 | VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE | Ideas For Medicine, Inc. | 1996-09-19 | Traditional | PDF ↗ |
| K954760 | LMI ARTERIAL EMBOLECTOMY CATHETER | Lucas Medical, Inc. | 1996-04-11 | Traditional | PDF ↗ |
| K955125 | LMI OCCLUSION CATHETER | Lucas Medical, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K950586 | AVD INTIMAX THROMBECTOMY CATHETER | Applied Medical Resources | 1995-05-15 | Traditional | PDF ↗ |
| K935405 | ARTERIAL EMBOLECTOMY | J-Lloyd Medical, Inc. | 1994-07-25 | Traditional | PDF ↗ |
| K920823 | WELTER SNARE RETRIEVER | Cook, Inc. | 1993-03-04 | Traditional | PDF ↗ |
| K920871 | J-LLOYD ARTERIAL EMBOLECTOMY CATHETER | J-Lloyd Medical, Inc. | 1993-02-26 | Traditional | PDF ↗ |
| K914880 | DUAL BALLOON EMBOLECTOMY CATHETER | Ideal Medical, Inc. | 1992-03-16 | Traditional | PDF ↗ |
| K910372 | INTIMAX THROMBECTOMY CATHETER | Applied Vascular Devices, Inc. | 1991-04-26 | Traditional | PDF ↗ |
| K905139 | CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER | Cathlab Corp. | 1991-02-25 | Traditional | PDF ↗ |
| K902327 | EMBOLECTOMY CATHETER | Clincal Instruments Corp. | 1991-02-25 | Traditional | PDF ↗ |
| K901502 | AMPLATZ GOOSE-NECK SNARE | Microvena Corp. | 1990-12-03 | Traditional | PDF ↗ |
| K901627 | ARTERIAL EMBOLECTOMY CATHETER | Applied Vascular Devices, Inc. | 1990-10-19 | Traditional | PDF ↗ |
| K900311 | ARTERIAL EMBOLECTOMY CATHETER | Impra, Inc. | 1990-07-17 | Traditional | PDF ↗ |
| K901625 | FOGARTY ARTERIAL EMBOLECTOMY II CATHETER | Baxter Healthcare Corp | 1990-07-06 | Traditional | PDF ↗ |
| K897184 | 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS | Cathlab Corp. | 1990-03-14 | Traditional | PDF ↗ |
| K883852 | CATHETER, CARDIOVASCULAR, BALLOON TYPE | Wb Intl., Inc. | 1989-12-07 | Traditional | PDF ↗ |
| K894681 | REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER | Shiley, Inc. | 1989-10-12 | Traditional | PDF ↗ |
| K891021 | TRI-LUMEN INTRA VASCULAR BALLOON CATHETER | Ideal Medical, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K893680 | SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. | Cathlab Corp. | 1989-08-01 | Traditional | PDF ↗ |
| K892410 | FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER | Baxter Healthcare Corp | 1989-07-20 | Traditional | PDF ↗ |
| K881455 | EMBOLECTOMY CATHETER(MODIFIED) | Cathlab Corp. | 1988-06-15 | Traditional | PDF ↗ |
| K872485 | CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) | Ideas For Medicine, Inc. | 1987-08-12 | Traditional | PDF ↗ |
| K864062 | PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) | Ideas For Medicine, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K864330 | SHEAR FORCE GAUGE | American Edwards Laboratories | 1987-01-06 | Traditional | PDF ↗ |
| K864007 | EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER | Uresil Corp. | 1987-01-02 | Traditional | PDF ↗ |
| K853625 | NOVA ARTERIAL EMBOLECTOMY CATHETER | Nova Medical Specialties | 1986-01-15 | Traditional | PDF ↗ |
| K850015 | POLYMED LAB ARTERIAL EMBOLECTOMY CATHETER | Polymed Laboratories | 1985-06-19 | Traditional | PDF ↗ |
| K840198 | ARTERIAL EMBOLECTOMY CATHETER | Shiley, Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K832044 | SHILEY MULTIPRO CATHETER | Shiley, Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K832023 | EMBOLECTOMY CATHETER | Bionomy, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K820646 | ATRAC TM MULTIPURPOSE BALLOON CATHETER | Atrium Medical Corp. | 1982-03-25 | Traditional | PDF ↗ |
| K812640 | URE SIL EMBOLECTOMY/THROMBECTOMY CATH | Uresil Corp. | 1981-10-02 | Traditional | PDF ↗ |
| K801650 | DESERET EMBOLECTOMY/THROMBECTOMY CATH. | Deseret Medical, Inc. | 1980-08-04 | Traditional | PDF ↗ |
| K790838 | ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) | Shiley, Inc. | 1979-06-11 | Traditional | PDF ↗ |
| K780762 | EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE | Shiley, Inc. | 1978-05-26 | Traditional | PDF ↗ |
| K780244 | CATHETERS, ARTERIAL EMBOLECTOMY | Extracorporeal Medical Specialities, Inc. | 1978-04-13 | Traditional | PDF ↗ |
| K770714 | CATHETER, ARTERIAL EMBOLECTOMY | Mallinckrodt Critical Care | 1977-04-27 | Traditional | PDF ↗ |
| K770569 | CATHETER, EMBOLECTOMY, UMI | Universal Medical Instrument Corp. | 1977-04-05 | Traditional | PDF ↗ |
| K761031 | ELECATH ARTERIAL EMBOLECTOMY CATHETER | Electro-Catheter Corp. | 1976-12-13 | Traditional | PDF ↗ |
Product code DXE · Class II · Cardiovascular. Data: openFDA.