SeQure
Drakon and SeQure are microcatheters intended for infusing contrast media into peripheral vessels. The filing also describes drug infusion in intra-arterial therapy and infusion of embolic…
Drakon and SeQure are microcatheters intended for infusing contrast media into peripheral vessels. The filing also describes drug infusion in intra-arterial therapy and infusion of embolic materials. These catheters are sterile, single-lumen devices for single use.
Their inner lumen is made from PTFE to permit passage of fluids, embolic agents and devices such as guidewires. The distal shaft has a hydrophilic polymer coating that becomes lubricious when wet with saline or blood, according to the subject-device description.
Listed Item
SeQure Microcatheter – 2.7 Fr. XSB, 130 cm, used with Extra Small Beads.
Catheter Construction
The filing specifies a PTFE inner lumen and a hydrophilic coating on the distal shaft. It describes the coating as lubricious when wet with saline or blood.
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (3), Zhejiang (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shenzhen Vivolight Medical Device&Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Record
| Listed by | Accurate Medical Therapeutics, Ltd., Israel |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| 510(k) | K202797 |
| Record published | 2021-07-22 |
| Record revised | 2026-07-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage. |
| Distribution end date | 2026-07-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SQ19_SB_130 | In distribution | |
| SQ27_XSB_155 | In distribution | |
| SQ19_SB_155 | In distribution | |
| SQ27_XSB_130 | Withdrawn | |
| SQ28_LB_130 | Withdrawn | |
| SQ27_MB_150 | Withdrawn | |
| SQ30_XLB_105 | Withdrawn | |
| SQ24_MB_105 | Withdrawn | |
| SQ27_MB_105 | Withdrawn | |
| SQ17_SB_155 | Withdrawn | |
| SQ30_XLB_155 | Withdrawn | |
| SQ17_SB_130 | Withdrawn | |
| SQ24_MB_130 | Withdrawn | |
| SQ27_MB_130 | Withdrawn | |
| SQ28_LB_150 | Withdrawn | |
| SQ19_SB_105 | Withdrawn | |
| SQ28_LB_105 | Withdrawn | |
| SQ30_XLB_130 | Withdrawn | |
| SQ24_MB_150 | Withdrawn | |
| SQ17_SB_105 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performa® | Merit Medical Systems, Inc. | 1,101 |
| Impress® | Merit Medical Systems, Inc. | 839 |
| Super Torque | Cordis Corp. | 611 |
| Soft-Vu | AngioDynamics, Inc. | 591 |
| Torcon NB | Cook Incorporated | 463 |
| Mariner | AngioDynamics, Inc. | 323 |
| INT,SlideCath | Shanghai Kindly Medical Instruments Co., Ltd. | 264 |
| Infiniti | Cordis Corp. | 251 |
| Infiniti | Cordis US Corp. | 241 |
| AngiOptic | AngioDynamics, Inc. | 227 |
| Tempo | Cordis Corp. | 217 |
| SiteSeer™ | Medtronic, Inc. | 204 |
Showing 12 of 226. All products under Catheter, Intravascular, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231293 | 2023-06-01 |
| K203487 | 2020-12-11 |
| K202797 | 2020-10-23 |
| K173430 | 2018-01-26 |
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.