Exel Safelet Catheter
by Exel Intl. 510(k)
Active
510(k) K895768
Overview
An IV catheter designed for peripheral venous access. It features a precision taper to assure smooth venipuncture with no catheter tip fold-back and is color-coded for easy size identification.
Supplied as a disposable, single-use device for professional use. It is a Class II medical device requiring a prescription and is available in various sizes, including 22G x 1" and 20G x 1".
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK895768 | Date16 Feb 1990 | 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- Withdrawn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 Exel Intl.
Questions
What is the EXEL SAFELET CATHETER used for?
The EXEL SAFELET CATHETER is designed for peripheral venous access, allowing healthcare professionals to insert an IV line into a patient's vein for fluid administration, medication delivery, or blood sampling. Its precision taper helps ensure smooth insertion and reduces the risk of catheter tip fold-back during venipuncture.
Is the EXEL SAFELET CATHETER reusable or single-use?
The EXEL SAFELET CATHETER is supplied as a disposable, single-use device intended for one-time use only. This design helps prevent cross-contamination and ensures patient safety by eliminating the need for reprocessing between uses.
What sizes is the EXEL SAFELET CATHETER available in?
The EXEL SAFELET CATHETER is available in various sizes, including 22G x 1" and 20G x 1", with color-coding to assist in quick and accurate size identification during clinical use. These sizes cater to different patient needs and vein accessibility requirements.