Stanicor, Omni-Stan,Mod 333B,334A Gamma
FDA 510(k) K792348 · Cordis Corp.
510(k) numberK792348
Submission
- Device name
- Stanicor, Omni-Stan,Mod 333B,334A Gamma
- Applicant
- Cordis Corp.
Mchenry, IL, US - Received
- November 19, 1979
- Decision date
- December 5, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTX – Gas Control Unit, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was Stanicor, Omni-Stan,Mod 333B,334A Gamma cleared by the FDA?
Stanicor, Omni-Stan,Mod 333B,334A Gamma (K792348) received a 510(k) decision of Substantially Equivalent on December 5, 1979, 16 days after the submission was received.
What is the product code of K792348?
The FDA product code is DTX – Gas Control Unit, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4300.