X-Wire Guidewire— 510(k) K244061
Substantially EquivalentImperative Care, Inc.
FDA 510(k) clearance K244061 for X-Wire Guidewire, Substantially Equivalent on 2025-08-26. Applicant: Imperative Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- Code MOF
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Campbell, CA, US
Recent devices under product code MOF
view allMore clearances from Imperative Care, Inc.
view all- K261176 — Zoom 4S Catheter
- K252046 — Zoom System (Zoom 4S Catheter)
- K252057 — Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System
- 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 MOF
product code MOF- Death
- 6
- Injury
- 137
- Total
- 143
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.