Atlas FDA

OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302

FDA 510(k) clearance K022145 · decided 2003-01-14

Clearance details

K-number
K022145
Device name
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
Applicant
LeMaitre Vascular, Inc.
Decision
Substantially Equivalent
Date received
2002-07-02
Decision date
2003-01-14
Days to decision
196 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Burlington, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44, recall (Z-1750-2025)LeMaitre Vascular, Inc.2025-05-12
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88 recall (Z-1567-2020)LeMaitre Vascular, Inc.2020-04-01
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 40cm, Model 1651-34 and e1651-34. Indicate recall (Z-0378-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. Indicated for the rem recall (Z-0379-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 4F, 80cm, Model 1651-48 and e1654-48. Indicate recall (Z-0380-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 80cm, Model 1651-88 and e1654-88. Ind recall (Z-0381-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. Indicate recall (Z-0382-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for recall (Z-0383-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. Indicated for the recall (Z-0384-2016)LeMaitre Vascular, Inc.2015-12-04
LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the recall (Z-0385-2016)LeMaitre Vascular, Inc.2015-12-04

PMA approvals by this applicant

RecordFirmDate
Artegraft Collagen Vascular Graft (N16837/S036)LeMaitre Vascular, Inc.2025-06-11
Artegraft Collagen Vascular Graft (N16837/S035)LeMaitre Vascular, Inc.2024-12-18
Artegraft Collagen Vascular Graft (N16837/S034)LeMaitre Vascular, Inc.2024-10-17
Artegraft Collagen Vascular Graft (N16837/S033)LeMaitre Vascular, Inc.2024-05-02
Artegraft Collagen Vascular Graft (N16837/S032)LeMaitre Vascular, Inc.2023-09-19
Artegraft Collagen Vascular Graft (N16837/S031)LeMaitre Vascular, Inc.2023-06-29
Artegraft Collagen Vascular Graft (N16837/S030)LeMaitre Vascular, Inc.2023-04-25
Artegraft Collagen Vascular Graft (N16837/S029)LeMaitre Vascular, Inc.2023-01-25