Data / Medical devices / Vietnam / CPT Sutures Co., Ltd.
CPT Sutures Co., Ltd.: FDA-registered device maker in Ho Chi Minh City, Vietnam, 1 510(k) clearance
CPT Sutures Co., Ltd. is registered with the FDA (registration 3018064853) in Ho Chi Minh City, Vietnam. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 29, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018064853
- Address
- 8 Dao Tri Street, Phu Thuan Ward, Ho Chi Minh City, Vietnam, 70000
- Owner or operator
- CPT SUTURES CO., LTD. (10080643)
- Roles
- Manufacturer
- First device listed
- February 17, 2021
- Registered through
- 2026
- Brand names listed
- CARESORB® - Polyglactin 910; CARESORB® RAPID (fast absorbing), CARESYN® - Polyglycolic Acid; CARESYN® RAPID, Synthetic Absorbable Suture, TEKSYN® 910 - Polyglactin 910 (PGLA); Rapid (fast absorbing), TEKSYN® PGA - Polyglycolic Acid (PGA); Rapid, Synthetic Absorbable Suture
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 29, 2017 | K170166 | CARESORB-Polyglactin 910 Surgical Suture, CARESORB-Polyglactin 910 (fast absorbing) Surgical Suture | GAM | Substantially Equivalent | Cpt Sutures Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 29, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.