Quantum Pump Console— 510(k) K173834
Substantially EquivalentSpectrum Medical , Ltd.
FDA 510(k) clearance K173834 for Quantum Pump Console, Substantially Equivalent on 2018-05-25. Applicant: Spectrum Medical , Ltd.. Device class: 2.
Clearance details
- Applicant
- Spectrum Medical , Ltd.
- Product code
- Code DTQ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4220
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gloucester, GB
Recent devices under product code DTQ
view allMore clearances from Spectrum Medical , Ltd.
view allAdverse events under product code DTQ
product code DTQ- Death
- 123
- Malfunction
- 4,822
- Other
- 1
- Total
- 4,946
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 K173834
K-number listed on FDA's recall record- Z-0224-2025 — Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00
- Z-2238-2019 — Quantum Pump Console
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173834.
Data sourced from openFDA. This site is unofficial and independent of the FDA.