Bendit2.7 Steerable Microcatheter
The Bendit2.7 Steerable Microcatheter delivers diagnostic, embolic or therapeutic materials into peripheral vessels. It is intended for general peripheral intravascular use and must not be…
The Bendit2.7 Steerable Microcatheter delivers diagnostic, embolic or therapeutic materials into peripheral vessels. It is intended for general peripheral intravascular use and must not be used in intracranial or coronary vessels.
A slider on the proximal handle deflects the tip, which locks when the slider is released. A torque knob rotates the deflected tip in either direction. The catheter’s radiopaque distal tip supports fluoroscopic positioning, while a hydrophilic coating covers the distal shaft.
Listed Item
The Bendit2.7™ Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature.
Catheter Access
The working length is 130 cm and the lumen accepts compatible guidewires no larger than 0.018 inch. A proximal luer-lock port connects accessories to the catheter lumen.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Vascupatent Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 1 |
Record
| Listed by | Bend IT Technologies Ltd., Israel |
|---|---|
| FDA product code | KRA |
| Device type | Catheter, Continuous Flush |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1210 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K200582 |
| Record published | 2020-08-24 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 3, pack of 5, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BDT01200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fountain® | Merit Medical Systems, Inc. | 154 |
| PulseSpray | AngioDynamics, Inc. | 149 |
| Merit Maestro® | Merit Medical Systems, Inc. | 143 |
| Phenom™ Catheter | Cathera, Inc. | 103 |
| UniFuse | AngioDynamics, Inc. | 84 |
| CXI | Cook Incorporated | 48 |
| Uni-Fuse+ | AngioDynamics, Inc. | 32 |
| Prowler | Medos International Sàrl | 27 |
| Truwave, Vamp | Edwards Lifesciences Technology Sarl | 26 |
| ICU Medical | ICU Medical, Inc | 21 |
| Cantata | Cook Incorporated | 20 |
| Truwave, Vamp Plus | Edwards Lifesciences Technology Sarl | 19 |
Showing 12 of 149. All products under Catheter, Continuous Flush
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200582 | 2020-06-25 |
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.