Filter Set Pmf 200
510(k) K760630
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760630 | Date15 Oct 1976 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KOC
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5820
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Filter Set Pmf 200 is a medical device classified as an accessory for blood circuits in hemodialysis. It is substantially equivalent to other devices and has a product code of KOC. The device is related to the medical specialty of Gastroenterology and Urology.
The Filter Set Pmf 200 is supplied by Sorensen Research and has an FDA 510K authorization with the clearance number K760630. The device has a regulation number of 876.5820 and is classified as a class 2 device. It is registered with the FDA and has a unique registration number.