# K051042: Metricath Gemini-P Balloon Catheter, Models RX2515S-P, RX3015S-P, RX3515S-P, RX4015S-P, Metricath Console, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Angiometrx, Inc.
- Decided: Aug 5, 2005 after 102 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- 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 no predicate by number.

## Indications for use
The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for: * Balloon dilatation of the stenotic portion of an arterial lesion * Post-delivery expansion of balloon expandable stents * Measurement of arterial lumen cross sectional area and diameter proximal to a lesion, or within a stented section of artery.

Source page: https://510kreport.com/device/K051042
Methodology: https://510kreport.com/methodology