SafeGuide®
Guidewire with Spring Tip - Single Use
9manufacturers in China registered for this device type
25catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Jiangsu Grit Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Jiangsu Power-Endo Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 7 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Diversatek Healthcare Inc, United States |
|---|---|
| FDA product code | KNQ |
| Device type | Dilator, Esophageal |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2022-06-10 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, High-level Disinfectant |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 3, case of 2, case of 6 |
| Sizes | Catheter gauge 15 to 60 Fr; length 86 to 210 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1214-02 | Length 210 cm | In distribution | |
| 1214-02S | Length 210 cm | In distribution | |
| 1214-60 | Catheter Gauge 60 Fr | In distribution | |
| 1214-04 | Length 210 cm | 25 | In distribution |
| 1214-03RS | Length 86 cm | In distribution | |
| 1214-15 | Catheter Gauge 15 Fr | In distribution | |
| 1214-39 | Catheter Gauge 39 Fr | In distribution | |
| 1214-57 | Catheter Gauge 57 Fr | In distribution | |
| 1214-10 | In distribution | ||
| 1214-03D | Length 86 cm | In distribution | |
| 1214-03R | Length 86 cm | In distribution | |
| 1214-54 | Catheter Gauge 54 Fr | In distribution | |
| 1214-33 | Catheter Gauge 33 Fr | In distribution | |
| 1214-51 | Catheter Gauge 51 Fr | In distribution | |
| 1214-18 | Catheter Gauge 18 Fr | In distribution | |
| 1214-36 | Catheter Gauge 36 Fr | In distribution | |
| 1214-00 | In distribution | ||
| 1214-24 | Catheter Gauge 24 Fr | In distribution | |
| 1214-27 | Catheter Gauge 27 Fr | In distribution | |
| 1214-45 | Catheter Gauge 45 Fr | In distribution | |
| 1214-48 | Catheter Gauge 48 Fr | In distribution | |
| 1214-30 | Catheter Gauge 30 Fr | In distribution | |
| 1214-02D | Length 210 cm | In distribution | |
| 1214-42 | Catheter Gauge 42 Fr | In distribution | |
| 1214-21 | Catheter Gauge 21 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable Dilation Balloon | Micro-Tech (Nanjing) Co., Ltd. | 99 |
| Reliant(TM) Multistage Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 37 |
| Quantum TTC | Cook Incorporated | 27 |
| Savary Gilliard | Cook Incorporated | 26 |
| Eliminator | ConMed Corporation | 21 |
| ABC Dilatation Balloon Catheter | Micro-Tech (Nanjing) Co., Ltd. | 21 |
| Flex-Ez Over the Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Flex-Ez Stylet Wire Balloon Dilator | Hobbs Medical, Inc. | 19 |
| Elation 5™ | Merit Medical Systems, Inc. | 18 |
| SafeGuide® Single | Diversatek Healthcare Inc | 16 |
| Conmed CleanGuide | Jiangsu Grit Medical Technology Co., Ltd. | 16 |
| Conmed | ConMed Corporation | 16 |
Showing 12 of 40. All products under Dilator, Esophageal
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-03-18 | Class II | Labeling Change Control | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | 15 units |
| 2026-03-18 | Class II | Labeling Change Control | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | 527 units |
| 2026-03-18 | Class II | Labeling Change Control | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | 1383 units |
| 2026-03-18 | Class II | Labeling Change Control | The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage. | 250 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.