Arterial Blood Filter #AF-1025
510(k) K820044
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820044 | Date29 Jun 1982 | 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- Withdrawn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
- DTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4260
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Arterial Blood Filter #AF-1025 is a Filter, Blood, Cardiopulmonary Bypass, Arterial Line device, designed to remove particulate matter from arterial blood during cardiopulmonary bypass procedures. It functions as a mechanical barrier to trap emboli, debris, or air bubbles, thereby protecting the patient’s circulatory system from potential complications. This device is specifically intended for use in arterial lines to ensure filtered blood flow during surgical interventions requiring extracorporeal circulation.
This device is supplied as a single-use, sterile product and is classified under FDA product code DTM as a Class II medical device with special controls. It is intended for use in controlled clinical environments such as operating rooms or cardiac catheterization labs. The filter is regulated under 21 CFR 870.4260 and was granted FDA 510(k) clearance in 1982 (K820044) following a review by the Cardiovascular (CV) Advisory Committee. No third-party certification is indicated in the regulatory records.