Tentacles NEO
This Product is a device used as a heart positioner particularly for Off-Pump CABG (Coronary Artery Bypass Grafting). Three (3) Suction Cups are attached to the surface of the heart by…
This Product is a device used as a heart positioner particularly for Off-Pump CABG (Coronary Artery Bypass Grafting). Three (3) Suction Cups are attached to the surface of the heart by means of suction pressure applied to each one of them. Traction Tubes are pulled and clamped to the surgical drape by Forceps in order to fix the position of the heart.
Who Else Makes It
Concentrated in Guangdong (3), Beijing (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Maquet (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 6 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
| Sumitomo Bakelite (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Beijing Yuewei Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Sb-Kawasumi Laboratories, Inc., Japan |
|---|---|
| FDA product code | MWS |
| Device type | Stabilizer, Heart |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Premarket notification | Exempt |
| Record published | 2019-11-15 |
| Record revised | 2022-05-30 (version 4) |
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 |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD-27320A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Octopus® | Medtronic, Inc. | 11 |
| Heart Stabilizer Finger Attachment | Sontec Instruments, Inc. | 6 |
| Heartline Stabilizer Arm | Sontec Instruments, Inc. | 6 |
| Starfish™ | Medtronic, Inc. | 4 |
| Stabilizer Tips | Sontec Instruments, Inc. | 4 |
| Urchin® | Medtronic, Inc. | 3 |
| Acrobat-I Stabilizer | Maquet Cardiovascular LLC | 2 |
| Viper II Heart Stabilizer | KDL Medical, Inc. | 2 |
| Viper II Apical Lift | KDL Medical, Inc. | 2 |
| Acrobat-i Positioner | Maquet Cardiovascular LLC | 2 |
| Acrobat SUV Stabilizer | Maquet Cardiovascular LLC | 2 |
| Starfish® EVO | Medtronic, Inc. | 2 |
Showing 12 of 36. All products under Stabilizer, Heart
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.