Vascufil
Coated Monofilament Polybutester,CV-Coated Monofilament Polybutester
6manufacturers in China registered for this device type
64catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Covidien LP, United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| 510(k) | K990952 |
| Record published | 2020-07-19 |
| Record revised | 2026-08-03 (version 14) |
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 |
| Storage | Storage environment temperature up to 130 °F |
| Packaging | Case of 36, case of 12 |
| Sizes | Length 18 to 36 in |
| Distribution end date | 2026-06-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 88864750-31V | diameter,4/0,N/A; | In distribution |
| 8886471021V-2 | diameter,5/0,N/A; | In distribution |
| 88864788-05V | Length 24 in | In distribution |
| 88864750-51V | diameter,2/0,N/A; | In distribution |
| 8886471631V-2 | Length 36 in | In distribution |
| 8886471121V-2 | Length 36 in | In distribution |
| 88864704-01V | Length 30 in | In distribution |
| 88864710-21V | diameter,5/0,N/A; | In distribution |
| 88864705-11V | Length 24 in | In distribution |
| 8886473921V-2 | diameter,5/0,N/A; | Withdrawn |
| 88864719-31V | Length 36 in | Withdrawn |
| 8886470411V-2 | Length 30 in | Withdrawn |
| 8886470511V-2 | Length 24 in | Withdrawn |
| 88864703-11V | Length 18 in | Withdrawn |
| 88864703-01V | diameter,7/0,N/A; | Withdrawn |
| 8886471621V-2 | diameter,5/0,N/A; | Withdrawn |
| 8886470501V-2 | Length 24 in | Withdrawn |
| 88864734-11V | Length 30 in | Withdrawn |
| XX2209 | Length 30 in | Withdrawn |
| 88864739-31V | diameter,4/0,N/A; | Withdrawn |
| 88864711-21V | Length 36 in | Withdrawn |
| 8886470911V-2 | Length 24 in | Withdrawn |
| 88864742-15V | diameter,6/0,N/A; | Withdrawn |
| 88864795-05V | diameter,7/0,N/A; | Withdrawn |
| 8886471011V-2 | diameter,6/0,N/A; | Withdrawn |
| 8886470311V-2 | diameter,6/0,N/A; | Withdrawn |
| 88864794-01V | Length 24 in | Withdrawn |
| XX-2122 | Length 30 in | Withdrawn |
| 88864739-21V | Length 30 in | Withdrawn |
| 88864714-01V | Length 24 in | Withdrawn |
| XX-2140 | Length 36 in | Withdrawn |
| 88864702-05V | diameter,7/0,N/A; | Withdrawn |
| 88864719-21V | Length 36 in | Withdrawn |
| 8886470921V-2 | diameter,5/0,N/A; | Withdrawn |
| 88864734-21V | Length 30 in | Withdrawn |
| 8886470105V-2 | Length 30 in | Withdrawn |
| 88864731-31V | Length 36 in | Withdrawn |
| 88864709-21V | Length 24 in | Withdrawn |
| 88864731-41V | diameter,3/0,N/A; | Withdrawn |
| 88864710-11V | diameter,6/0,N/A; | Withdrawn |
| 88864730-51V | Length 36 in | Withdrawn |
| 88864707-11V | Length 18 in | Withdrawn |
| 8886473931V-2 | diameter,4/0,N/A; | Withdrawn |
| XX2208 | Diameter, 4/0, N/A; | Withdrawn |
| 8886470205V-2 | Length 24 in | Withdrawn |
| 88864714-11V | diameter,6/0,N/A; | Withdrawn |
| 8886472221V-2 | Length 30 in | Withdrawn |
| 8886470711V-2 | diameter,6/0,N/A; | Withdrawn |
| 88864731-51V | diameter,2/0,N/A; | Withdrawn |
| 88864756-11V | Length 30 in | Withdrawn |
| 8886471931V-2 | Diameter,4/0,N/A; | Withdrawn |
| 88864722-21V | Length 30 in | Withdrawn |
| 88864709-11V | Length 24 in | Withdrawn |
| 88864701-05V | Length 30 in | Withdrawn |
| 8886470301V-2 | Length 18 in | Withdrawn |
| 88864716-21V | Length 36 in | Withdrawn |
| 88864741-21V | Length 30 in | Withdrawn |
| 88864705-01V | diameter,7/0,N/A; | Withdrawn |
| 88864741-11V | diameter,6/0,N/A; | Withdrawn |
| 88864750-41V | Length 36 in | Withdrawn |
| 88864704-11V | Length 30 in | Withdrawn |
| 88864726-41V | Length 30 in | Withdrawn |
| 88864716-31V | Length 36 in | Withdrawn |
| 8886471921V-2 | Length 36 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 48492 units |
| Covidien | 510(k) number | 2022-12-02 | Class II | Packaging process control | Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact | 40152 units |
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | Davis & Geck, Inc. |
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.