Fogarty Corkscrew
Fogarty Corkscrew is a flexible catheter for removing emboli or thrombi from adult peripheral arteries, including native vessels and synthetic grafts. Its spiral distal cable provides a…
Fogarty Corkscrew is a flexible catheter for removing emboli or thrombi from adult peripheral arteries, including native vessels and synthetic grafts. Its spiral distal cable provides a surface for entrapping fibrous material.
A PVC outer body surrounds a movable radiopaque stainless-steel spring. A second radiopaque stainless-steel spiral cable, covered by a latex membrane, attaches at the distal end.
Listed Item
Fogarty Corkscrew Catheter 5F 8MM 80CM
Manual Control
A proximal handle changes the spiral cable diameter through the inner spring body. The catheter is supplied sterile for single use, with its mechanical capture configuration distinct from a balloon catheter.
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Edwards Lifesciences Technology Sarl, United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K233619 |
| Record published | 2016-09-03 |
| Record revised | 2026-01-15 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: STORE IN A COOL, DRY PLACE. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 140808 | CATHETER FRENCH SIZE: 5F (1.67MM), USABLE LENGTH: 80 CM, MAXIMUM DIAMETER OF EXTENDED MEMBRANE: 3.1MM, DIAMETER OF CONTRACTED MEMBRANE: 8MM | In distribution |
| 1408010 | CATHETER FRENCH SIZE: 6F (2.00MM), USABLE LENGTH: 80 CM, MAXIMUM DIAMETER OF EXTENDED MEMBRANE: 3.3MM, DIAMETER OF CONTRACTED MEMBRANE: 10MM | In distribution |
| 140806 | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 80 CM, MAXIMUM DIAMETER OF EXTENDED MEMBRANE: 2.7MM, DIAMETER OF CONTRACTED MEMBRANE: 6MM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LeMaitre Embolectomy Catheter | Lemaitre Vascular, Inc. | 68 |
| LMI Arterial Embolectomy Catheter | Lucas Medical, Inc. | 63 |
| Indigo System | Penumbra Inc. | 60 |
| Fogarty | Edwards Lifesciences Technology Sarl | 44 |
| Arrow | Teleflex Medical LLC | 28 |
| Bard Latex-free Arterial Embolectomy Catheters | Applied Medical Resources Corp. | 22 |
| Biosensors Embolectomy Catheter | Bioptimal International Pte. Ltd. | 16 |
| Amplatz Goose Neck | Covidien LP | 15 |
| Amplatz Goose Neck™ | ev3, Inc. | 13 |
| LMI Thrombectomy Catheter | Lucas Medical, Inc. | 12 |
| LMI Occlusion Catheter | Lucas Medical, Inc. | 12 |
| Syntel Thrombectomy Catheter | Applied Medical Resources Corp. | 9 |
Showing 12 of 88. All products under Catheter, Embolectomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240078 | 2024-08-28 |
| K241330 | 2024-07-02 |
| K233819 | 2024-05-22 |
| K233820 | 2024-05-22 |
| K233619 | 2024-05-20 |
| K193379 | 2020-06-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 2017-07-06 | Class II | Packaging | The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. | 200 units | 2018-10-17 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-09-07 | Class II | Nonconforming Material/Component | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). | 185 |
| 2022-10-06 | Class II | Packaging | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. | 26,560 units |
| 2022-10-06 | Class II | Packaging | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. | 715,620 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.