# K042685: Metricath System

- Pathway: 510(k) (Traditional)
- Applicant: Angiometrx, Inc.
- Decided: Nov 18, 2004 after 50 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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 no predicate by number.

## Most influential descendants
- K091780: Guided Measurement Catheter (GMC) (2009), 1 descendant of its own
- K142235: CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter (2014), 0 descendants of its own

## Indications for use
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery.

Source page: https://510kreport.com/device/K042685
Methodology: https://510kreport.com/methodology