TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER— 510(k) K100282
Substantially EquivalentTerumo Corp.
FDA 510(k) clearance K100282 for TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER, Substantially Equivalent on 2010-02-26. Applicant: Terumo Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Corp.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Elkton, MD, US
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- K073474 — CAPIOX CIRCUIT CONNECTORS
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Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.