# K993694: Mikro-Tip Angiographic Catheter

- Pathway: 510(k) (Special)
- Applicant: Millar Instruments, Inc.
- Decided: Mar 1, 2000 after 120 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 3 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Mar 8, 2011 · Not classified · Z-1725-2011: Possibility of epoxy debris particles inside the catheter lumen.
- Oct 14, 2010 · Not classified · Z-0401-2011: The sterile packaging was found to be compromised when tested after shipping conditions. This may result in infection or transmission of disease. A test for transportation of sterile package was condu
- Jan 14, 2005 · Not classified · Z-0635-05: Wire braiding protruding from the catheter.

## Indications for use
The Millar Angiographic catheter is designed to provide high fidelity pressure readings and deliver radiopaque contrast medium to selected sites in the vascular system.

Source page: https://510kreport.com/device/K993694
Methodology: https://510kreport.com/methodology