Syntel Silicone OTW Embolectomy Catheter
9 catalogue numbers from A4E09, listed by Lemaitre Vascular, Inc., United States, under Catheter, Embolectomy. 1 manufacturer in China is registered for this product code.
1manufacturer
9catalogue numbers in this listing
1510(k) clearance
22recalls 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 | Lemaitre Vascular, Inc., United States |
|---|---|
| FDA product code | DXE |
| Device type | Catheter, Embolectomy |
| Device class | Class 2 |
| Regulation | 21 CFR 870.5150 |
| Establishment | Manufacturer |
| 510(k) | K970762 |
| Record published | 2021-06-18 |
| Record revised | 2022-10-24 (version 2) |
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: Keep away from sunlight; Special storage condition: Keep dry |
| Sizes | Catheter working length 40 to 80 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A4E09 | In distribution | |
| A4E04 | In distribution | |
| A4E05 | In distribution | |
| A4E01 | Catheter Working Length 40 cm | In distribution |
| A4E03 | Catheter Working Length 40 cm | In distribution |
| A4E06 | In distribution | |
| A4E02 | Catheter Working Length 80 cm | In distribution |
| A4E07 | In distribution | |
| A4E08 | 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 |
|---|---|
| K022145 | 2003-01-14 |
Recalls Naming This Product
2 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 | Closed |
|---|---|---|---|---|---|---|---|
| Applied Medical Resources Corp. | 510(k) number | 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
| Applied Medical Resources Corp. | 510(k) number | 2019-10-24 | Class I | Component change control | The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter. | 28,799 catheters in total | 2023-06-01 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2025-04-11 | Class II | Packaging process control | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | 237,611 units | |
| 2024-04-17 | Class II | Under Investigation by firm | The guide tip can become damaged and result in the tip detaching. | 5,604 units | |
| 2022-09-30 | Class II | Process design | Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the catheter and block the inflation hole, leading to the risk of | 72 (OUS only) | |
| 2020-03-23 | Class I | Process control | There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. | 43315 | |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2015-10-21 | Class II | Packaging process control | Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility. | 4315 total | 2019-07-12 |
| 2005-02-07 | Not classified | Other | Product sterility maybe compromised due to defective packaging | 312 units | 2005-07-25 |
| 2005-02-07 | Not classified | Other | Product sterility maybe compromised due to defective packaging | 713 units | 2005-07-25 |
| 2005-02-07 | Not classified | Other | Product sterility maybe compromised due to defective packaging | 411 units | 2005-07-25 |
| 2005-02-07 | Not classified | Other | Product sterility maybe compromised due to defective packaging | 692 units | 2005-07-25 |
| 2005-02-07 | Not classified | Other | Product sterility maybe compromised due to defective packaging | 100 units | 2005-07-25 |
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.