Accel®
Accel Valved Centesis 5FX7CM 20G NO Clip
7manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Jiangsu Yangtze River Medical Technology Corp. | Taizhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | GCB |
| Device type | Needle, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-20 |
| Record revised | 2020-06-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 613235 | Length : 10.000 CM | 5 | In distribution |
| 613234 | Length : 15.000 CM | 5 | In distribution |
| 613152 | 5 | In distribution | |
| 613230 | Length : 7.000 CM | 5 | In distribution |
| 613153 | 5 | In distribution | |
| 613155 | 5 | In distribution | |
| 613231 | Length : 10.000 CM | 5 | In distribution |
| 613232 | Length : 7.000 CM | 5 | In distribution |
| 613233 | Length : 10.000 CM | 5 | In distribution |
| 613151 | 5 | In distribution | |
| 613154 | 5 | In distribution | |
| 613150 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MAK-NV™ | Merit Medical Systems, Inc. | 26 |
| Cook | Cook Incorporated | 17 |
| Ring-McLean | Cook Incorporated | 16 |
| Jet-Vac Procedure Trays | PFM Medical, Inc | 16 |
| Access Needle | Mermaid Medical A/S | 11 |
| Teleflex | Teleflex Medical LLC | 8 |
| Ring | Cook Incorporated | 7 |
| M-Drain Centesis Catheter | Mermaid Medical A/S | 6 |
| Accel™ | B. Braun Interventional Systems, Inc. | 5 |
| Pilling | Teleflex Medical LLC | 4 |
| Accel Centesis Catheter | PFM Medical, Inc | 4 |
| Skater™ Introducer System | Argon Medical Devices, Inc. | 3 |
Showing 12 of 30. All products under Needle, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K150800 | 2015-11-12 |
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.