# K883880: Katzen Thrombolysis Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Medi-Tech, Inc.
- Decided: Apr 6, 1989 after 205 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033569: Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath (2004), 1 descendant of its own
- K082163: Flowmedica Benephit Infusion Systems (2008), 0 descendants of its own
- K971719: Therox Infusion Guidewires (1997), 0 descendants of its own

## Recalls of this device
- Aug 1, 2011 · Not classified · Z-3053-2011: Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The
- Dec 12, 2006 · Not classified · Z-0642-2007: Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually

Source page: https://510kreport.com/device/K883880
Methodology: https://510kreport.com/methodology