Cook
Mini Compression Dual Balloon Catheter with Silicone Balloons
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Hotry Co., Ltd. | Beijing | Beijing | Manufacturer | 9 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | HAO |
| Device type | Instrument, Surgical, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4535 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
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: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G10325 | In distribution | |
| G10324 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 705 |
| Ambler Surgical | Ambler Surgical, LLC | 597 |
| V. Mueller | Steris Corporation | 577 |
| Millennium | Avalign Technologies, Inc. | 383 |
| Avalign | Avalign Technologies, Inc. | 352 |
| Novo Surgical | Novo Surgical, Inc. | 300 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 283 |
| Boss Instruments | Boss Instruments, Ltd. | 263 |
| Pilling | Teleflex Medical LLC | 156 |
| Instrument, Surgical, Non-Powered | Karl Storz GmbH & Co. KG | 130 |
| Instrument, Surgical, Non-Powered | Fehling Instruments GmbH | 126 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 109 |
Showing 12 of 249. All products under Instrument, Surgical, Non-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940973 | 1995-09-29 |
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.