Product code DTY— Cardiovascular
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
- Classification name
- Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass
- Device class
- Class 2
- Regulation
- 21 CFR 870.4410
- Advisory panel
- Cardiovascular
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code DTY
FDA has cleared devices under product code DTY between 1982 and 2010, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2010
- 1997
- 1996
- 1990
- 1987
- 1984
- 1982
Top applicants under product code DTY
Recent clearances under product code DTY
- K093650 — BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM
- K963698 — CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4
- K954501 — BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
- K902654 — CDI (TM) SYSTEM 100 MONITORING SYSTEM
- K900860 — PERFUSION MONITOR
- K864703 — MODIFIED GAS-STAT(TM) MONITORING SYSTEM
- K840749 — GAST STAT MONITORING SYSTEM
- K822000 — EXTRACORPOREAL BLOOD GAS SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.