# K193647: Superpipe Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Hengrui Disheng Medical Co., Ltd.
- Decided: Jul 29, 2020 after 212 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
Longest line of descent: 3 generations back to K921310 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992051: Radifocus Optitorque, Terumo Medical Corp. (1999) Summary page 4.

## Indications for use
The SUPERPIPE Angiographic Catheter is intended for use in angiographic procedures. It delivers radiopaque media, guide wires, catheters, and therapeutic agents to selected sites in the vascular system.

Source page: https://510kreport.com/device/K193647
Methodology: https://510kreport.com/methodology