MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR— 510(k) K030449
Substantially EquivalentTerumo Corp.
FDA 510(k) clearance K030449 for MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR, Substantially Equivalent on 2003-03-05. Applicant: Terumo Corp.. Device class: 2.
Clearance details
- Applicant
- Terumo Corp.
- Product code
- Code DTN
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Elkton, MD, US
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- K073474 — CAPIOX CIRCUIT CONNECTORS
Adverse events under product code DTN
product code DTN- Death
- 3
- Total
- 3
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.