Ventrio
Ventrio ST Hernia Patch, 27.4 cm x 34.9 cm (10.8" x 13.7"), Oval
1manufacturer
18catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Davol Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| Record published | 2015-06-19 |
| Record revised | 2025-08-18 (version 7) |
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, manufacturing date |
| Storage | Storage environment temperature 2 to 25 °C |
| Sizes | Width 8 to 27.4 cm; length 12 to 34.9 cm; outer diameter 7.6 to 11.4 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0010217 | Width 27.4 cm | In distribution |
| 0010212 | Width 13.8 cm | In distribution |
| 0010211 | Length 12 cm | In distribution |
| 5950090 | Width 27.4 cm | In distribution |
| 5950010 | Outer Diameter 7.6 cm | In distribution |
| 0010215 | Width 11 cm | In distribution |
| 5950050 | Length 17.8 cm | In distribution |
| 5950040 | Length 14.0 cm | In distribution |
| 5950080 | Length 27.1 cm | In distribution |
| 0010214 | Outer Diameter 11.4 cm | In distribution |
| 0010218 | Width 19.6 cm | In distribution |
| 5950060 | Length 25.7 cm | In distribution |
| 5950070 | Length 24.6 cm | In distribution |
| 5950030 | Width 8.0 cm | In distribution |
| 5950020 | Outer Diameter 11.4 cm | In distribution |
| 0010213 | Outer Diameter 7.6 cm | In distribution |
| 0010216 | Length 27.1 cm | In distribution |
| 0010219 | Length 25.7 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technical Products | Technical Products, Inc. | 143 |
| Parietex | Sofradim Production | 82 |
| DynaMesh | FEG Textiltechnik Forschungs- und Entwicklungsges. mbH | 45 |
| Symbotex | Sofradim Production | 35 |
| Silicone Sheeting Reinforced | Bentec Medical OpCo, LLC. | 33 |
| Parietene | Sofradim Production | 32 |
| C-QUR | Atrium Medical Corporation | 31 |
| ProGrip | Sofradim Production | 31 |
| Silicone Sheeting Non-Reinforced | Bentec Medical OpCo, LLC. | 31 |
| Prolite | Atrium Medical Corporation | 31 |
| Gore Seamguard Bioabsorbable Staple Line Reinforce | W. L. Gore & Associates, Inc. | 30 |
| Surgimesh®wn | Aspide Medical | 28 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251557 | 2025-06-12 |
| K250098 | 2025-04-09 |
| K003323 | 2001-01-22 |
| K792281 | 1979-11-27 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990028 | 2003-12-04 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corporation |
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.