Heparin Coated Stainless Steel/Teflon
by Argon Medical Corp. 510(k)
Active
510(k) K832030
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832030 | Date29 Sep 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DOX
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3550
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Heparin Coated Stainless Steel/Teflon is a medical device made of stainless steel and Teflon with a heparin coating. It is classified as a class 2 device. The device is described as substantially equivalent.
The device is supplied by Argon Medical Corp. and has FDA 510(k) clearance with the clearance number K832030. It is regulated under the product code DOX and has a regulation number of 862.3550. The device is registered with the FDA and has a registration number of 3003915875 and 1625425.
Other devices from Argon Medical Corp.
Questions
AI-generated answers, 27 Sep 2026
What is the Heparin Coated Stainless Steel/Teflon device made of?
The device is made of stainless steel and Teflon with a heparin coating, designed for clinical applications.
Is the Heparin Coated Stainless Steel/Teflon device supplied sterile?
The device data does not specify sterility, it is essential to follow proper handling and storage procedures.
What is the regulatory classification of the Heparin Coated Stainless Steel/Teflon device?
The device is classified as a class 2 device, regulated under the product code DOX with a regulation number of 862.3550.