Multi-Lumen Intravenous Infusion Cath
FDA 510(k) K833825 · Medical Parameters, Inc.
510(k) numberK833825
Submission
- Device name
- Multi-Lumen Intravenous Infusion Cath
- Applicant
- Medical Parameters, Inc.
Walker, MI, US - Received
- November 2, 1983
- Decision date
- January 10, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Multi-Lumen Intravenous Infusion Cath cleared by the FDA?
Multi-Lumen Intravenous Infusion Cath (K833825) received a 510(k) decision of Substantially Equivalent on January 10, 1984, 69 days after the submission was received.
What is the product code of K833825?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.