TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support— 510(k) K240948
Substantially EquivalentImperative Care, Inc.
FDA 510(k) clearance K240948 for TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support, Substantially Equivalent on 2024-06-06. Applicant: Imperative Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Imperative Care, Inc.
- Product code
- 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.