# K000825: 4F-7F Medi-Dyne Torq Flow XLB Angiographic Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Dyne, Inc.
- Decided: Sep 21, 2000 after 191 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K090427: Ursa Angiographic Catheter (2010), 1 descendant of its own
- K123818: Ursa Angiographic Catheter (2013), 0 descendants of its own

## Recalls of this device
- Nov 21, 2002 · Not classified · Z-0593-03: 6 Fr. catheters packaged and labeled as 5 Fr.

Source page: https://510kreport.com/device/K000825
Methodology: https://510kreport.com/methodology