Instrument, Surgical, Disposable
Vascular Loops, Sterile, Blue, Super Maxi, 18-inch long, 2 per package
45manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (11), Shanghai (7). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Anhui Medfaith Medical Devices Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 6 |
| Shanghai Kohope Medical Devices Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 45. All 45 manufacturers in China registered for Instrument, Surgical, Disposable
Record
| Listed by | Key Surgical, LLC, United States |
|---|---|
| FDA product code | KDC |
| Device type | Instrument, Surgical, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K896676 |
| Record published | 2023-09-25 |
| Record revised | 2025-03-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Sizes | Length 18 in |
| Distribution end date | 2025-03-14 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Vascular Loops | Length 18 in | 2 | In distribution |
| Vascular Loops | Length 18 in | 2 | In distribution |
| Vascular Loops | 2 | In distribution | |
| Vascular Loops | Length 18 in | 2 | In distribution |
| Vascular Loops | Diameter Cross Section 1.3mm x 0.9mm | In distribution | |
| Vascular Loops | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 213 |
| DeRoyal | Deroyal Industries, Inc. | 167 |
| Medical Action Industries | Medical Action Industries, Inc. | 112 |
| Centurion | Centurion Medical Products Corporation | 98 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 77 |
| Sterion® Vessel Loop | Aspen Surgical Products, Inc. | 47 |
| Sterion®Clamp Cover Fabric | Aspen Surgical Products, Inc. | 31 |
| Integra | Provision | 26 |
| Devon | Cardinal Health | 25 |
| Instrument, Surgical, Disposable | Summit Medical LLC | 23 |
| Dermapac, Inc. | Dermapac Inc. | 22 |
| CareFusion 2200 | Provision | 20 |
Showing 12 of 155. All products under Instrument, Surgical, Disposable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K896676 | 1990-02-27 |
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.