Vizigo
3 catalogue numbers from D138501, listed by Biosense Webster, Inc., United States, under Introducer, Catheter. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
12recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Biosense Webster, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K170997 |
| Record published | 2018-05-09 |
| Record revised | 2026-03-23 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| D138501 | In distribution | |
| D138502 | In distribution | |
| D138503 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231412 | 2023-07-10 |
| K170997 | 2017-07-25 |
| K001139 | 2000-05-10 |
Recalls Naming This Product
7 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Biosense Webster, Inc. | 510(k) number | 2024-02-16 | Class II | Under Investigation by firm | Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process. | 853 units |
| Biosense Webster, Inc. | 510(k) number | 2023-02-21 | Class II | Under Investigation by firm | Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch | 277 |
| Biosense Webster, Inc. | 510(k) number | 2023-02-21 | Class II | Under Investigation by firm | Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch | 316 units |
| Biosense Webster, Inc. | 510(k) number | 2022-06-29 | Class II | Material/Component Contamination | Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised sterile barrier could b | 98 |
| Biosense Webster, Inc. | 510(k) number | 2021-02-26 | Class II | Device Design | There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism | 71,473 units |
| Biosense Webster, Inc. | 510(k) number | 2021-02-26 | Class II | Device Design | There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism | |
| Biosense Webster, Inc. | 510(k) number | 2021-02-26 | Class II | Device Design | There is a potential for the hemostatic valve to dislodge while introducing the dilator or device into the sheath. This could result in minor bleeding and/or embolism |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-11-17 | Not classified | Other | Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium. | 26,173 | 2009-06-25 |
| 2006-11-17 | Not classified | Other | Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium. | 401 | 2009-06-25 |
| 2006-11-17 | Not classified | Other | Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium. | 182 | 2009-06-25 |
| 2006-11-17 | Not classified | Other | Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium. | 4565 | 2009-06-25 |
| 2006-11-17 | Not classified | Other | Biosense Webster, Inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the PREFACE Sheath during use in the left atrium. | 996 | 2009-06-25 |
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.