Flow Controlling Extension Set
FDA 510(k) K935236 · Block Medical, Inc.
510(k) numberK935236
Submission
- Device name
- Flow Controlling Extension Set
- Applicant
- Block Medical, Inc.
Carlsbad, CA, US - Received
- November 1, 1993
- Decision date
- February 24, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LDR – Controller, Infusion, Intravascular, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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Questions and answers
When was Flow Controlling Extension Set cleared by the FDA?
Flow Controlling Extension Set (K935236) received a 510(k) decision of Substantially Equivalent on February 24, 1994, 115 days after the submission was received.
What is the product code of K935236?
The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.