Fogarty
The Fogarty Arterial Embolectomy Catheter is indicated to remove fresh, soft emboli and thrombi from vessels in the arterial system. A separate device in the filing, the Fogarty Biliary…
The Fogarty Arterial Embolectomy Catheter is indicated to remove fresh, soft emboli and thrombi from vessels in the arterial system. A separate device in the filing, the Fogarty Biliary Balloon Probe, is intended for removal of stones and ductal debris and for exploration.
The biliary probe is a single-lumen PVC catheter with a latex balloon at its distal end and an inflation hub proximally. It is supplied with a flexible stylet designed to maintain shape while facilitating introduction through sharply angled areas. The filing identifies these devices as sterile and single-use.
Listed Item
Cath,fogarty ART EMB 2FR 60CM Flat Pack W/NAT RUB Latex,ster
Separate Device Roles
The submission distinguishes the arterial catheter from the biliary probe: the arterial device is not intended for fibrous or adherent material, while the probe is indicated for stones, ductal debris and exploration.
1manufacturer
44catalogue numbers in this listing
6510(k) clearances naming this product code
4recalls on this code
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) | K193379 |
| Record published | 2016-09-03 |
| Record revised | 2024-10-29 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| 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. |
| Packaging | Shipper of 5 |
| Distribution end date | 2028-09-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12A0804F | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 80 CM | In distribution |
| 120807FP | CATHETER FRENCH SIZE: 7F (2.3MM), USABLE LENGTH: 80CM | In distribution |
| 12A0803F | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 80 CM | In distribution |
| 120803FS | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 80CM | In distribution |
| 120803FP | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 80CM | In distribution |
| 320808F | CATHETER FRENCH SIZE: 8.0F (2.7MM), USABLE LENGTH: 80CM | In distribution |
| 12TLW406F | CATHETER FRENCH SIZE: 6F (2.0MM), USABLE LENGTH: 40 CM, MINIMUM INTRODUCER SIZE: 7F (2.3MM) | In distribution |
| 12A0602F | CATHETER FRENCH SIZE: 2F (0.67MM), USABLE LENGTH: 60CM | In distribution |
| 120805FP | CATHETER FRENCH SIZE: 5F (1.67MM), USABLE LENGTH: 80CM | In distribution |
| 12TLW807F | CATHETER FRENCH SIZE: 7F (2.3MM), USABLE LENGTH: 80 CM, MINIMUM INTRODUCER SIZE: 8F (2.7MM) | In distribution |
| 12A0805F | CATHETER FRENCH SIZE: 5F (1.67MM), USABLE LENGTH: 80CM | In distribution |
| 120806FP | CATHETER FRENCH SIZE: 6F (2.00MM), USABLE LENGTH: 80CM | In distribution |
| 12A0403F | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 40 CM | In distribution |
| 120403FS | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 40CM | In distribution |
| 12A1004F | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 100 CM | In distribution |
| 120602FP | CATHETER FRENCH SIZE: 2F (0.67MM), USABLE LENGTH: 60CM | In distribution |
| 120803FSP | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 80CM | In distribution |
| 120804F | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 80CM | In distribution |
| 320806F | CATHETER FRENCH SIZE: 6.0F (2.0MM), USABLE LENGTH: 80CM | In distribution |
| 12A0806F | CATHETER FRENCH SIZE: 6F (2.0MM), USABLE LENGTH: 80 CM | In distribution |
| 120602F | CATHETER FRENCH SIZE: 2F (0.67MM), USABLE LENGTH: 60CM | In distribution |
| 120807F | CATHETER FRENCH SIZE: 7F (2.3MM), USABLE LENGTH: 80 CM | In distribution |
| 12GV0402F | CATHETER FRENCH SIZE: 2F (0.67MM), USABLE LENGTH: 45 CM | In distribution |
| 12TLW1203F | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 120 CM, MINIMUM INTRODUCER SIZE: 4.5F (1.50MM) | In distribution |
| 120403FP | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 40CM | In distribution |
| 12TLW403F | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 40 CM, MINIMUM INTRODUCER SIZE: 4.5F (1.50MM) | In distribution |
| 120403FSP | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 40CM | In distribution |
| 12TLW803F | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 80 CM, MINIMUM INTRODUCER SIZE: 4.5F (1.50MM) | In distribution |
| 120804FP | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 80CM | In distribution |
| 12TLW806F | CATHETER FRENCH SIZE: 6F (2.0MM), USABLE LENGTH: 80 CM, MINIMUM INTRODUCER SIZE: 7F (2.3MM) | In distribution |
| 120806F | CATHETER FRENCH SIZE: 6F (2.0MM), USABLE LENGTH: 80 CM | In distribution |
| 12TLW804F | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 80 CM, MINIMUM INTRODUCER SIZE: 5F (1.67MM) | In distribution |
| 12A0404F | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 40 CM | In distribution |
| 12A0807F | CATHETER FRENCH SIZE: 7F (2.3MM), USABLE LENGTH: 80 CM | In distribution |
| 120403F | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 40CM | In distribution |
| 12TLW405F35 | CATHETER FRENCH SIZE: 5.5F (1.83MM), USABLE LENGTH: 40 CM, MINIMUM INTRODUCER SIZE: 6F (2.00MM) | In distribution |
| 120805F | CATHETER FRENCH SIZE: 5F (1.67MM), USABLE LENGTH: 80CM | In distribution |
| 12TLW404F | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 40 CM, MINIMUM INTRODUCER SIZE: 5F (1.67MM) | In distribution |
| 120804FF | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 80 CM | In distribution |
| 120404FP | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 40CM | In distribution |
| 12TLW805F35 | CATHETER FRENCH SIZE: 5.5F (1.83MM), USABLE LENGTH: 80 CM, MINIMUM INTRODUCER SIZE: 6F (2.00MM) | In distribution |
| 120803F | CATHETER FRENCH SIZE: 3F (1.00MM), USABLE LENGTH: 80CM | In distribution |
| 120404F | CATHETER FRENCH SIZE: 4F (1.33MM), USABLE LENGTH: 40CM | In distribution |
| 32080810F | CATHETER FRENCH SIZE: 8.0F (2.7MM), USABLE LENGTH: 80CM | 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 |
| 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 |
| Syntel Silicone OTW Embolectomy Catheter | Lemaitre Vascular, Inc. | 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
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Edwards Lifesciences Technology Sarl | 510(k) number | 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 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 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 |
| Edwards Lifesciences Technology Sarl | 510(k) number | 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 |
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2017-07-06 | Class II | Packaging | The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. | 200 units | 2018-10-17 |
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.