Syvek Patch
Syvek is a 3 cm x 3 cm patch used for vascular hemostasis
3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (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 |
|---|---|---|---|---|
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Marine Polymer Technologies, Inc., United States |
|---|---|
| FDA product code | KMF |
| Device type | Bandage, Liquid |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5090 |
| Establishment | Manufacturer |
| 510(k) | K984177 |
| Record published | 2020-01-20 |
| Record revised | 2025-02-05 (version 3) |
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 | Box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400-02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PolyMem | Ferris MFG. Corp. | 60 |
| 3M™ Cavilon™ | 3M Company | 54 |
| Kendall | Cardinal Health | 23 |
| Kendall | Cardinal Health 200, LLC | 15 |
| Curity | Cardinal Health | 11 |
| GluSeal® | Glustich Inc | 7 |
| Stratis | Covidien LP | 7 |
| Curity | Cardinal Health 200, LLC | 6 |
| Tritis | Covidien LP | 4 |
| GluSeal®90 | Glustich Inc | 3 |
| Medline | Medline Industries, Inc. | 3 |
| GluSeal®90 | Skinstitch Corp. | 2 |
Showing 12 of 29. All products under Bandage, Liquid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082703 | 2008-10-14 |
| K002550 | 2000-12-20 |
| K984177 | 1998-12-18 |
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.