Leonard/Norton Hyperalimentation Cathet
by Norton Performance Plastics Corp.
510(k) K821679
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821679 | Date2 Jul 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- Withdrawn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
- FOZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5200
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Leonard/Norton Hyperalimentation Cathet is a medical device used for hyperalimentation. It is designed to provide nutrition to patients. The device is a type of catheter, which is a tube used for injecting or withdrawing fluids from the body.
The Leonard/Norton Hyperalimentation Cathet is supplied by Norton Performance Plastics Corp. It has been granted FDA 510(k) clearance, with the decision code SESE, indicating that it is substantially equivalent to other devices on the market. The device has a product code of FOZ and a k number of K821679.
Other devices from Norton Performance Plastics Corp.
Questions
AI-generated answers, 6 Oct 2026
What is the Leonard/Norton Hyperalimentation Cathet used for?
The Leonard/Norton Hyperalimentation Cathet is used for hyperalimentation, providing nutrition to patients through a tube.
Who supplies the Leonard/Norton Hyperalimentation Cathet?
The device is supplied by Norton Performance Plastics Corp.
What is the regulatory status of the Leonard/Norton Hyperalimentation Cathet?
The device has been granted FDA 510(k) clearance, indicating it is substantially equivalent to other devices on the market.