# K013073: Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima and Saf-T-Intima Intravascular Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Infusion Therapy Systems, Inc.
- Decided: Nov 8, 2001 after 55 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Insyte™ IV Catheter: named in the summary without a submission number
- (no number) Angiocath™ IV Catheter: named in the summary without a submission number
- (no number) Insyte™ Autoguard™ IV Catheter: named in the summary without a submission number
- (no number) Angiocath™ Autoguard™ IV Catheter: named in the summary without a submission number
- (no number) Autoguard™ Pro IV Catheter: named in the summary without a submission number
- (no number) Intima™ IV Catheter: named in the summary without a submission number
- (no number) Saf-T-Intima™ IV Catheter: named in the summary without a submission number

## Most influential descendants
- K063469: Medican Alpha (2006), 0 descendants of its own

## Indications for use
As provided in 21 CFR 880.5200, an intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Source page: https://510kreport.com/device/K013073
Methodology: https://510kreport.com/methodology