# K210996: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing

- Pathway: 510(k) (Special)
- Applicant: Imperative Care, Inc.
- Decided: Apr 23, 2021 after 21 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
Longest line of descent: 2 generations back to K183043 (2019). 2 ancestors in all.
5 later devices descend from it; 3 cite 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)
- K202182: ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing, Imperative Care, Inc. (2020) Summary page 4.

## Most influential descendants
- 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
- K242672: Zoom System (2025), 0 descendants of its own
- K234083: Next Generation Aspiration Catheter; Balt Aspiration Tubing Set (2024), 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.

## Indications for use
The ZOOM Reperfusion Catheters, with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump), are indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral — M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The ZOOM Aspiration Tubing is intended to connect the ZOOM Reperfusion Catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

Source page: https://510kreport.com/device/K210996
Methodology: https://510kreport.com/methodology