Cook
Flow Directed Balloon Catheter
1manufacturer
2catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | DYG |
| Device type | Catheter, Flow Directed |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1240 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2023-12-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2017-10-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G09278 | Withdrawn | |
| G10851 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 115 |
| Transonic | Transonic Systems, Inc. | 12 |
| Corodyn | B. Braun Medical Inc. | 10 |
| Venos Occlusion Balloon Catheter | Oscor Inc. | 9 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 9 |
| Graftmaster | Abbott Vascular | 9 |
| Swan-Ganz | Edwards Lifesciences Technology Sarl | 7 |
| Pruitt Occlusion Catheter | Lemaitre Vascular, Inc. | 6 |
| Swan-Ganz VIP | Edwards Lifesciences Technology Sarl | 3 |
| Swan-Ganz | Becton, Dickinson AND Company | 3 |
| Swan Ganz Catheter | Edwards Lifesciences Technology Sarl | 2 |
| Swan-Ganz Ccombo | Edwards Lifesciences Technology Sarl | 2 |
Showing 12 of 23. All products under Catheter, Flow Directed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K831185 | 1983-05-27 |
| K770522 | 1977-03-30 |
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.