FDA 510(k) clearance · back to tracker

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

Imperative Care, Inc. cleared K243047 on 2025-05-28, decision: substantially equivalent

K-number

K243047

Sponsor

Imperative Care, Inc.

Device

Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-05-28

Product code

NRY

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.1250

Official FDA record

Open K243047on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K243047 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.