Accel Centesis Catheter
5F x 15cm ACCEL Centesis Catheter Percutaneous Fluid Drainage
7manufacturers in China registered for this device type
4catalogue numbers in this listing
3recalls on this code
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 | PFM 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-29 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 613212 | In distribution | |
| 613210 | In distribution | |
| 613214 | In distribution | |
| 613211 | 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 |
| Accel® | B. Braun Medical Inc. | 12 |
| 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 |
| Skater™ Introducer System | Argon Medical Devices, Inc. | 3 |
Showing 12 of 30. All products under Needle, Catheter
Recalls
3 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 |
|---|---|---|---|---|---|
| 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 480 units | 2015-04-23 |
| 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 75 units | 2015-04-23 |
| 2014-10-20 | Class II | Process control | PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin. | 85 units | 2015-04-23 |
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.