# K972623: Lmi Irrigation Catheter (Igr)

- Pathway: 510(k) (Traditional)
- Applicant: Lucas Medical, Inc.
- Decided: Nov 19, 1997 after 128 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fogarty Irrigation Catheter: named in the summary without a submission number
- (no number) Intimax Irrigating Catheter: named in the summary without a submission number

## Most influential descendants
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own
- K050130: Kerberos Proximal Solutions Rispiration System (2005), 16 descendants of its own
- K062275: Rinspiration Catheter System, Models 50135, 550135, P7065, P70135 (2006), 9 descendants of its own
- K080901: Lbi Embolectomy System (2008), 6 descendants of its own
- K113757: Aspire Max Aspiration Catheter (2012), 5 descendants of its own

## Indications for use
The LMI Irrigation Catheter is intended for intra-operative procedures requiring irrigation in either arterial or venous blood vessels.

Source page: https://510kreport.com/device/K972623
Methodology: https://510kreport.com/methodology