AngioDynamics
Stiffened Micro Introducer Kit
13manufacturers in China registered for this device type
14catalogue numbers in this listing
4510(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 | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K051655 |
| Record published | 2016-09-19 |
| Record revised | 2024-03-20 (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 |
| Storage | Storage environment temperature up to 27 °C |
| Packaging | Box of 10 |
| Sizes | Catheter gauge 4 to 5 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 06597032 | Catheter Gauge 4 Fr | In distribution |
| 06597067 | Catheter Gauge 4 Fr | In distribution |
| 06597060 | Catheter Gauge 5 Fr | In distribution |
| 06597022 | Catheter Gauge 5 Fr | In distribution |
| 06597003 | Catheter Gauge 4 Fr | In distribution |
| 06597033 | Catheter Gauge 5 Fr | In distribution |
| 06597017 | Catheter Gauge 4 Fr | In distribution |
| 06597034 | Catheter Gauge 4 Fr | In distribution |
| 06597068 | Catheter Gauge 5 Fr | In distribution |
| 06597101 | Catheter Gauge 4 Fr | In distribution |
| 06597021 | Catheter Gauge 4 Fr | In distribution |
| 06597010 | Catheter Gauge 5 Fr | In distribution |
| 06597041 | Catheter Gauge 5 Fr | In distribution |
| 06597028 | Catheter Gauge 4 Fr | 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 |
|---|---|
| K170775 | 2017-07-19 |
| K170695 | 2017-05-30 |
| K040728 | 2004-06-18 |
| K964034 | 1997-05-06 |
Recalls Naming This Product
9 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 | Closed |
|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2020-10-14 | Class II | Under Investigation by firm | 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component | 32 kits | 2021-10-19 |
| AngioDynamics, Inc. | 510(k) number | 2016-09-28 | Class III | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub du | 162 boxes | 2018-06-18 |
| AngioDynamics, Inc. | 510(k) number | 2016-09-28 | Class III | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub du | 80 boxes | 2018-06-18 |
| AngioDynamics, Inc. | 510(k) number | 2016-09-28 | Class III | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub du | 751 units | 2018-06-18 |
| AngioDynamics, Inc. | 510(k) number | 2016-09-28 | Class III | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub du | 996 boxes | 2018-06-18 |
| AngioDynamics, Inc. | 510(k) number | 2016-09-28 | Class III | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub du | 145 boxes | 2018-06-18 |
| AngioDynamics, Inc. | 510(k) number | 2016-09-28 | Class II | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub du | 7 boxes | 2018-06-18 |
| AngioDynamics, Inc. | 510(k) number | 2016-09-28 | Class III | Component design/selection | Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub du | 4 boxes | 2018-06-18 |
| AngioDynamics, Inc. | 510(k) number | 2013-04-30 | Class II | Labeling mix-ups | AngioDynamics Inc., is recalling Micro Introducer Kits and VenaCure EVLT NeverTouch Procedure Kits, because the potential exists that the micro Introducer (sheath/dilator) packaged within the kit could be the incorrect French size. | Domestic(1,760 units): 1)260 units/26 boxes, 2)310 units/31 | 2016-11-09 |
Recalls
2 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 | Closed |
|---|---|---|---|---|---|
| 2021-02-22 | Class II | Under Investigation by firm | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified be | 337 units, (14 boxes of 5, 267 units each kit) | 2022-07-19 |
| 2018-05-10 | Class II | Material/Component Contamination | A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). | 86 boxes | 2020-05-13 |
| 2011-08-01 | Not classified | Device Design | The product may contain an incorrect size catheter and introducer. | 1095 total units | 2012-03-07 |
| 2011-08-01 | Not classified | Device Design | The product may contain an incorrect size catheter and introducer. | 1095 total units | 2012-03-07 |
| 2004-06-24 | Not classified | Other | Product labeled to contain Emcee Obturators contained Emcee Dilators. | 90 units | 2005-07-21 |
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.