AtriClip Flex•v
AtriClip FLEX•V device 35
4manufacturers in China registered for this device type
12catalogue numbers in this listing
11510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Bana Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 4 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
Record
| Listed by | Atricure, Inc., United States |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2021-01-08 |
| Record revised | 2021-02-05 (version 5) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature from 20 °C |
| Packaging | Box, case of 12 |
| Sizes | Length 35 to 50 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACHV35 | Length 35 mm | In distribution |
| ACHV40 | Length 40 mm | In distribution |
| ACHV50 | Length 50 mm | In distribution |
| ACHV45 | Length 45 mm | In distribution |
| ACHV35 | Length 35 mm | In distribution |
| ACHV45 | Length 45 mm | In distribution |
| ACHV50 | Length 50 mm | In distribution |
| ACHV50 | Length 50 mm | In distribution |
| ACHV40 | Length 40 mm | In distribution |
| ACHV35 | Length 35 mm | In distribution |
| ACHV40 | Length 40 mm | In distribution |
| ACHV45 | Length 45 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Weck | Teleflex Medical LLC | 321 |
| Teleflex | Teleflex Medical LLC | 57 |
| AtriClip™ LAA Exclusion System | Atricure, Inc. | 40 |
| Aesculap | Aesculap AG | 19 |
| Medline | Medline Industries, Inc. | 15 |
| E-Pack | Ethicon, Inc. | 12 |
| AtriClip® Pro•v™ LAA Exclusion System | Atricure, Inc. | 12 |
| Titanium Ligation Clip | Vesocclude Medical, LLC | 11 |
| SLS-Clip | Vitalitec Surgical | 10 |
| SLS-Clip Vitalitec | Peters Surgical | 10 |
| MirusTM Ligating Clip | Meril Endo Surgery PVT. Ltd. | 10 |
| Clip 9 Vitalitec | Peters Surgical | 10 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180010 | 2018-01-31 |
| K173031 | 2017-10-25 |
| K172742 | 2017-10-11 |
| K163261 | 2017-05-19 |
| K160454 | 2016-03-18 |
| K153500 | 2016-01-27 |
| K150996 | 2015-06-17 |
| K142120 | 2014-08-28 |
| K131107 | 2013-05-14 |
| K122276 | 2012-08-29 |
| K093679 | 2010-06-10 |
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 |
|---|---|---|---|---|---|
| 2016-11-30 | Class II | Component design/selection | A complaint of the PRO2 jaw breaking prior to surgery being performed. | 464 units | 2018-02-15 |
| 2016-09-22 | Class II | Device Design | There is a potential for a component failure of the device which could necessitate medical intervention. | 298 | 2018-02-15 |
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.