BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI— 510(k) K850952
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K850952 for BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI, Substantially Equivalent on 1985-08-05. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, 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
- Murray Hill, NJ, 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
More clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
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.