Anastoclip AC Closure System
Anastoclip AC Closure System, medium (M)
4manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code
7recalls 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 | Lemaitre Vascular, Inc., United States |
|---|---|
| FDA product code | FZP |
| Device type | Clip, Implantable |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4300 |
| Establishment | Manufacturer |
| 510(k) | K962043 |
| Record published | 2015-06-30 |
| Record revised | 2021-04-21 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4000-08 | In distribution | |
| 4000-07 | In distribution | |
| 4000-05 | In distribution | |
| 4000-06 | 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 |
| AtriClip Flex•v | Atricure, Inc. | 12 |
| 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 |
Showing 12 of 70. All products under Clip, Implantable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173323 | 2018-03-08 |
| K091987 | 2010-04-23 |
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| Lemaitre Vascular, Inc. | 510(k) number | 2016-06-22 | Class II | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use | 256 units | 2021-04-08 |
| Lemaitre Vascular, Inc. | 510(k) number | 2016-06-22 | Class II | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. | 471 units | 2021-04-08 |
| Lemaitre Vascular, Inc. | 510(k) number | 2016-06-22 | Class II | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. | 170 units | 2021-04-08 |
| Lemaitre Vascular, Inc. | 510(k) number | 2016-06-22 | Class II | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. | 40 units (6-Pack) | 2021-04-08 |
| Lemaitre Vascular, Inc. | 510(k) number | 2016-06-22 | Class II | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. | 39 units | 2021-04-08 |
| Lemaitre Vascular, Inc. | 510(k) number | 2016-06-22 | Class II | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. | 55 units (6 pack) | 2021-04-08 |
| Lemaitre Vascular, Inc. | 510(k) number | 2016-06-22 | Class II | Unknown/Undetermined by firm | US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use. | 20 units | 2021-04-08 |
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.