Microfuse Intravenous Catheter Set
FDA 510(k) K840240 · Norton Performance Plastics Corp.
510(k) numberK840240
Submission
- Device name
- Microfuse Intravenous Catheter Set
- Applicant
- Norton Performance Plastics Corp.
Mchenry, IL, US - Received
- January 20, 1984
- Decision date
- April 17, 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 Microfuse Intravenous Catheter Set cleared by the FDA?
Microfuse Intravenous Catheter Set (K840240) received a 510(k) decision of Substantially Equivalent on April 17, 1984, 88 days after the submission was received.
What is the product code of K840240?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.