# K102633: Bioteq Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Sep 9, 2011 after 361 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). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970854: 5 FR  and 6 FR Infiniti Angiographic Catheter, Cordis Corp. (1997) Summary page 1.

## Indications for use
The "BIOTEQ" Angiographic Catheter is indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system. The device is for use in the coronary and peripheral vasculature, and not for use in the neurovasculature.

Source page: https://510kreport.com/device/K102633
Methodology: https://510kreport.com/methodology