Merge Hemo— 510(k) K152864
Substantially EquivalentMerge Healthcare Incorporated
FDA 510(k) clearance K152864 for Merge Hemo, Substantially Equivalent on 2016-04-07. Applicant: Merge Healthcare Incorporated. Device class: 2.
Clearance details
- Applicant
- Merge Healthcare Incorporated
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hartland, WI, US
Recent devices under product code DQK
view allMore clearances from Merge Healthcare Incorporated
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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 →
Recalls naming K152864
K-number listed on FDA's recall record- Z-2387-2021 — Merge Hemo, Software packages 10.2, 10.3, and 10.4
- Z-0350-2018 — Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152864.
Data sourced from openFDA. This site is unofficial and independent of the FDA.