Changes to Protectiv(Tm) & Jelco(Tm) Winged Cath
by Critikon Company, LLC 510(k)
Active
510(k) K933050
Overview
The Protectiv and Jelco Winged Cath is an intravenous catheter designed for clinical use. It facilitates vascular access for the administration of fluids or medications.
This device is identified under FDA 510(k) clearance K933050. It is manufactured by Critikon Company, LLC and is classified under the general hospital advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933050 | Date14 Dec 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Critikon Company, LLC
Questions
What is the primary clinical purpose of the Protectiv and Jelco Winged Cath?
This device is an intravenous catheter specifically designed to facilitate vascular access. It is intended for the administration of medications or fluids directly into a patient's circulatory system.
Who is the manufacturer of this intravenous catheter?
The Protectiv and Jelco Winged Cath is manufactured by Critikon Company, LLC, based in Tampa, Florida.
Is this device recognized by the FDA?
Yes, this device is identified under FDA 510(k) clearance number K933050. It was determined to be substantially equivalent to existing devices through a traditional clearance process.