# K974764: Introsyte Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Feb 26, 1998 after 69 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Infusion Therapy Systems INTROSYTE™ brand introducer catheters: named in the summary without a submission number
- (no number) Becton Dickinson Infusion Therapy Systems INSYTE® brand introducer catheters: named in the summary without a submission number
- (no number) Becton Dickinson Infusion Therapy Systems SPLIT SECOND® brand introducer catheters: named in the summary without a submission number
- (no number) Teleflex, Inc. Percutaneous Introducer Set: named in the summary without a submission number

## Recalls of this device
- Feb 3, 2004 · Not classified · Z-0586-04: Splittable catheter introducer may not fully split or may separate non-uniformly.
- Feb 3, 2004 · Not classified · Z-0587-04: Splittable catheter introducer may not fully split or may separate non-uniformly.

## Indications for use
TO FACILITATE THE PLACEMENT OF DEVICES SUCH AS GUIDEWIRES, INDWELLING CENTRAL VENOUS CATHETERS, PERIPHERALLY INSERTED CENTRAL VENOUS CATHETERS AND MIDLINE CATHETERS INTO THE VASCULAR SYSTEM.

Source page: https://510kreport.com/device/K974764
Methodology: https://510kreport.com/methodology