# K183043: 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Imperative Care, Inc.
- Decided: Apr 17, 2019 after 166 days
- Product code: NRY (Catheter, Thrombus Retriever)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
3 of 8 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 no predicate by number.

## Most influential descendants
- K202182: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (2020), 6 descendants of its own
- K210996: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (2021), 5 descendants of its own
- K211476: ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing (2021), 3 descendants of its own
- K243948: Raptor Aspiration Catheter; Balt Aspiration Tubing Set (2025), 0 descendants of its own
- K243047: Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing (2025), 0 descendants of its own

## Recalls of this device
- Aug 13, 2021 · Class I · Z-2577-2021: There is a potential for distal end of catheters to fracture and become detached.

Source page: https://510kreport.com/device/K183043
Methodology: https://510kreport.com/methodology