CATHETER, FLOW DIRECTED THERMAL DILUTION— 510(k) K760533
Substantially EquivalentGould, Inc.
FDA 510(k) clearance K760533 for CATHETER, FLOW DIRECTED THERMAL DILUTION, Substantially Equivalent on 1976-09-09. Applicant: Gould, Inc.. Device class: 2.
Clearance details
- Applicant
- Gould, Inc.
- Product code
- Code DYG
- Device class
- Class 2
- Regulation
- 21 CFR 870.1240
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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More clearances from Gould, Inc.
view allAdverse events under product code DYG
product code DYG- Death
- 18
- Malfunction
- 1,051
- Other
- 1
- Total
- 1,070
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.