Pruitt Occlusion Catheter
Pruitt Occlusion Catheter, 5F, eIFU
1manufacturer
6catalogue numbers in this listing
1recall
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 | Lemaitre Vascular, Inc., United States |
|---|---|
| FDA product code | DYG |
| Device type | Catheter, Flow Directed |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1240 |
| Establishment | Manufacturer |
| 510(k) | K811276 |
| Record published | 2015-06-30 |
| Record revised | 2023-12-04 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| e2103-56 | In distribution | |
| e2103-46 | In distribution | |
| 2103-36 | In distribution | |
| 2103-46 | In distribution | |
| e2103-36 | In distribution | |
| 2103-56 | In distribution |
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 |
| 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 |
| Cook | Cook Incorporated | 2 |
Showing 12 of 23. All products under Catheter, Flow Directed
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Lemaitre Vascular, Inc. | 510(k) number | 2025-04-11 | Class II | Packaging process control | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | 65,977 units |
| Lemaitre Vascular, Inc. | UDI-DI | 2025-04-11 | Class II | Packaging process control | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). | 26,872 units |
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.