Hesung Blood Transfusion Sets
510(k) K841562
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841562 | Date23 Jul 1984 | 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- Withdrawn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
- FPA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5440
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Hesung Blood Transfusion Sets are intravascular administration sets designed for the delivery of blood products. These devices facilitate the controlled transfer of blood to a patient during clinical procedures.
This device is identified by FDA 510(k) number K841562. It is classified under the general hospital medical specialty and has received FDA 510(k) clearance.
Other devices from Amkor Trading Co.
Questions
AI-generated answers, 25 Sep 2026
What is the primary purpose of the Hesung Blood Transfusion Set?
The Hesung Blood Transfusion Set is an intravascular administration device specifically designed to facilitate the controlled transfer and delivery of blood products to a patient during clinical procedures.
What is the regulatory status of this device?
This device has received FDA 510(k) clearance under the number K841562. It was determined to be substantially equivalent to existing devices through a traditional review process by the General Hospital advisory committee.
Who is the manufacturer of these transfusion sets?
The Hesung Blood Transfusion Sets are manufactured by Amkor Trading Co., located in Walker, Michigan.