SILICONE FLOW-DIRECTED THERMODILUTION CATHETER— 510(k) K893435
Substantially EquivalentCathlab Corp.
FDA 510(k) clearance K893435 for SILICONE FLOW-DIRECTED THERMODILUTION CATHETER, Substantially Equivalent on 1989-09-26. Applicant: Cathlab Corp.. Device class: 2.
Clearance details
- Applicant
- Cathlab Corp.
- 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
- Tustin, CA, US
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- K222117 — Swang-Ganz IQ pulmonary artery catheter
More clearances from Cathlab Corp.
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.