Zoom 6f Insert Catheter, SIM
The Zoom 6F Insert Catheter delivers radiopaque media to selected sites in the peripheral vascular system during routine diagnostic procedures. The SIM configuration has a pre-shaped distal…
The Zoom 6F Insert Catheter delivers radiopaque media to selected sites in the peripheral vascular system during routine diagnostic procedures. The SIM configuration has a pre-shaped distal curve and a 143 cm working length for catheter positioning using standard angiographic techniques.
The single-lumen catheter has a braid-reinforced shaft with variable stiffness, a proximal luer hub and a tapered distal tip. Its distal shaft and tip are radiopaque for visualization during placement.
Listed Item
Zoom 6F Insert Catheter, SIM, 143cm
Compatibility and Supply
It accepts guidewires no larger than 0.038 inches and at least 180 cm long, with a guide catheter inner diameter of at least 0.088 inches. It is compatible with standard luer-lock devices and is supplied sterile after ethylene oxide sterilization for single use.
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 | Imperative Care Inc., United States |
|---|---|
| FDA product code | DQO |
| Device type | Catheter, Intravascular, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K233975 |
| Record published | 2024-06-18 |
| Record revised | 2025-02-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.; Special storage condition: Store in a cool, dry place at room temperature. |
| Sizes | Catheter length 143 cm; outer diameter 0.082 in; lumen/inner diameter 0.041 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IC6FSIM143 | Catheter Length 143 cm | In distribution |
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 |
|---|---|
| K233975 | 2024-04-02 |
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.