FuStarTM Steerable introducer
- Primary DI
- 06938370117667
- Brand
- FuStarTM Steerable introducer
- Company
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Model
- SLB9F-900
- Device description
- The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or introducer sheath, which provides a pathway through whichdevices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low- profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of cathelters and devices.The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm(Large). Ineach option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination Also, the visible knob with scale of controller facillitates the physicians to estimate the deflecting angle of the sheath while intra-operation.The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French sie, 5F, 6F, 7F, 8F, 9F and 10F). The deflection angle of shealth is from 0 degree to 180 degree.
- Published
- 2017-11-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| DQY | Catheter, Percutaneous |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K100184 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06938370117667 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06938370117667 | 06938370117667 | 6938370117667 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cardiac occluder delivery kit | A collection of sterile devices designed to implant a cardiac occluder for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occlude; the cardiac occluder is not included. The devices are used in the treatment of cardiac disorders that may include (but not limited to) atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 529864170
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 06938370118015 | SeQureTM Snare System | LT-SG-05 | 2017-11-17 | |
| 06938370118022 | SeQureTM Snare System | LT-SG-10 | 2017-11-17 | |
| 06938370118039 | SeQureTM Snare System | LT-SG-15 | 2017-11-17 | |
| 06938370118046 | SeQureTM Snare System | LT-SG-20 | 2017-11-17 | |
| 06938370118053 | SeQureTM Snare System | LT-SG-25 | 2017-11-17 | |
| 06938370118060 | SeQureTM Snare System | LT-SG-30 | 2017-11-17 | |
| 06938370118077 | SeQureTM Snare System | LT-SG-35 | 2017-11-17 | |
| 06938370118084 | SeQureTM Snare System | LT-SP-10 | 2017-11-17 | |
| 06938370118091 | SeQureTM Snare System | LT-SP-25 | 2017-11-17 | |
| 06938370118107 | SeQureTM Snare System | LT-SM-02 | 2017-11-17 | |
| 06938370118114 | SeQureTM Snare System | LT-SM-04 | 2017-11-17 | |
| 06938370118121 | SeQureTM Snare System | LT-SM-07 | 2017-11-17 | |
| 06938370117049 | FuStarTM Steerable introducer | SLA5F-550 | 2017-11-03 | |
| 06938370117056 | FuStarTM Steerable introducer | SLA5F-700 | 2017-11-03 | |
| 06938370117063 | FuStarTM Steerable introducer | SLA5F-900 | 2017-11-03 | |
| 06938370117070 | FuStarTM Steerable introducer | SLA6F-550 | 2017-11-06 | |
| 06938370117087 | FuStarTM Steerable introducer | SLA6F-700 | 2017-11-06 | |
| 06938370117094 | FuStarTM Steerable introducer | SLA6F-900 | 2017-11-06 | |
| 06938370117100 | FuStarTM Steerable introducer | SLA7F-550 | 2017-11-06 | |
| 06938370117117 | FuStarTM Steerable introducer | SLA7F-700 | 2017-11-06 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 06934955914713 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914720 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914737 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914744 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914751 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914768 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914775 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914782 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914799 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914805 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914812 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914829 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914836 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914843 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914850 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914867 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914874 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914881 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914898 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914904 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914911 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 06934955914928 | Teleport Glide Microcatheter | OrbusNeich Medical (ShenZhen) Co., Ltd. | DQY | 2026-07-20 |
| 00810024671885 | CPS Locator 3D, Small Delivery Catheter | CENTERPOINT SYSTEMS LLC | DQY | 2026-07-13 |
| 00810024671892 | CPS Locator 3D, Medium Delivery Catheter | CENTERPOINT SYSTEMS LLC | DQY | 2026-07-13 |
| 00810024671908 | CPS Locator 3D, Large Delivery Catheter | CENTERPOINT SYSTEMS LLC | DQY | 2026-07-13 |
| 00810024671915 | CPS Locator 3D, Medium, Extra Long Delivery Catheter | CENTERPOINT SYSTEMS LLC | DQY | 2026-07-13 |
| 00810024671922 | CPS Locator 3D, Large, Extra Long Delivery Catheter | CENTERPOINT SYSTEMS LLC | DQY | 2026-07-13 |
| 00853799007930 | 8F Base Camp System 2.0 90cm | ROUTE 92 MEDICAL | DQY | 2026-07-08 |
| 10801902218732 | ARROW | TELEFLEX INCORPORATED | DQY | 2026-06-24 |
| 00810024671953 | SSPC NXT Delivery Catheter | CENTERPOINT SYSTEMS LLC | DQY | 2026-06-01 |