High Pressure SETS-400 Psi
FDA 510(k) K100576 · Icu Medical, Inc.
510(k) numberK100576
Submission
- Device name
- High Pressure SETS-400 Psi
- Applicant
- Icu Medical, Inc.
Salt Lake City, UT, US - Received
- March 1, 2010
- Decision date
- December 17, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was High Pressure SETS-400 Psi cleared by the FDA?
High Pressure SETS-400 Psi (K100576) received a 510(k) decision of Substantially Equivalent on December 17, 2010, 291 days after the submission was received.
What is the product code of K100576?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.