CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR— 510(k) K040210
Substantially EquivalentTerumo Corp.
FDA 510(k) clearance K040210 for CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR, Substantially Equivalent on 2004-03-03. Applicant: Terumo Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Corp.
- Product code
- Code DTZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4350
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elkton, MD, US
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More clearances from Terumo Corp.
view all- K100282 — TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
- K092372 — HEARTRAIL III GUIDING CATHETER
- K091417 — SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A
- K090973 — TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
- K073474 — CAPIOX CIRCUIT CONNECTORS
Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
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.