Zoom 4S Catheter— 510(k) K261176
Substantially EquivalentImperative Care, Inc.
FDA 510(k) clearance K261176 for Zoom 4S Catheter, Substantially Equivalent on 2026-08-28. Applicant: Imperative Care, Inc.. Device class: 2.
Summary
Imperative Care filed the Zoom 4S Catheter under product code QJP, percutaneous neurovasculature catheters. The record doesn't explain the 4S in the name.
Class II, 21 CFR 870.1250. Cardiovascular is the classification panel, but the Neurology review panel handled the submission, a Traditional 510(k).
The applicant filed from Campbell, California. Review took 140 calendar days (April 10 to August 28, 2026) and ended in a substantially equivalent decision.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- Product code QJP
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
Recent devices under product code QJP
view allMore clearances from Imperative Care, Inc.
view all- K252046 — Zoom System (Zoom 4S Catheter)
- K252057 — Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System
- K244061 — X-Wire Guidewire
- K243047 — Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
- K250775 — Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System
Adverse events under product code QJP
product code QJP- Death
- 43
- Injury
- 233
- Malfunction
- 1,010
- Total
- 1,286
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.