THERMAL DILUTION CATHETER— 510(k) K832324
Substantially EquivalentCatheter Corp. of America
FDA 510(k) clearance K832324 for THERMAL DILUTION CATHETER, Substantially Equivalent on 1983-11-03. Applicant: Catheter Corp. of America. Device class: 2.
Clearance details
- Applicant
- Catheter Corp. of America
- 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
- Walker, MI, US
Recent devices under product code DYG
view all- K242451 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) +2 more
- K233983 — Swan-Ganz Pacing Probe and Catheters +4 more
- K233824 — Swan-Ganz catheter
- K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
- K222117 — Swang-Ganz IQ pulmonary artery catheter
Adverse 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.