Multilumen Central Venous Cath. W/Vitacuff Device
by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)
Active
510(k) K882448
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882448 | Date9 Aug 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- LJS
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5970
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
This device is a multilumen central venous catheter with a Vitacuff component, classified as a catheter, intravascular, therapeutic, long-term greater than 30 days. It is intended for use in general hospital settings for vascular access.
The device is supplied as a single-use, sterile product and is regulated under FDA 510(k) clearance (K882448) with product code LJS. It received a substantially equivalent decision on August 9, 1988, and is subject to regulation number 880.5970.
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Questions
AI-generated answers, 19 Sep 2026
What is the purpose of the MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE?
This device is a multilumen central venous catheter with a Vitacuff component, intended for vascular access in general hospital settings for therapeutic use longer than 30 days.
How is the MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE supplied?
The device is supplied as a single-use, sterile product for patient safety and infection prevention purposes.
What is the regulatory status of this device?
The device has FDA 510(k) clearance (K882448) with product code LJS and received a substantially equivalent decision on August 9, 1988.
Can this device be reused on multiple patients?
No, this device is supplied as a single-use product and should not be reused on multiple patients to maintain sterility and prevent infection risks.