Micro Access
Stainless Steel Guidewire
9manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Guangdong (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Changzhou Lookmed Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 8 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | DRC |
| Device type | Trocar |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1390 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K051655 |
| Record published | 2016-09-20 |
| 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 | Length 4 to 60 cm; needle gauge 21 G; outer diameter 0.018 in; catheter gauge 4 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 06509909 | Catheter Gauge 4 Fr | In distribution |
| 06506803 | Length 4 cm | In distribution |
| 06507204 | Length 60 cm | In distribution |
| 06506801 | Needle Gauge 21 G | In distribution |
| 06506802 | Length 7 cm | In distribution |
| 06507202 | Outer Diameter 0.018 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 107 |
| Trocar | Doppkon Gmbh & Co. KG | 53 |
| Merit Advance® | Merit Medical Systems, Inc. | 39 |
| HeartSpan® | Merit Medical | 29 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 22 |
| Argyle | Cardinal Health | 20 |
| Apple-Hunt Secondary Cannula | Coopersurgical, Inc. | 20 |
| HeartSpan® | Merit Medical Systems, Inc. | 16 |
| AngioDynamics | AngioDynamics, Inc. | 16 |
| Majestik® | Merit Medical Systems, Inc. | 14 |
| Ambler Surgical | Ambler Surgical, LLC | 12 |
| Argyle | Cardinal Health 200, LLC | 8 |
Showing 12 of 57. All products under Trocar
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 |
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.