Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set
FDA 510(k) K072375 · AngioDynamics, Inc.
510(k) numberK072375
Submission
- Device name
- Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- August 23, 2007
- Decision date
- December 13, 2007
- 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 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set cleared by the FDA?
Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set (K072375) received a 510(k) decision of Substantially Equivalent on December 13, 2007, 112 days after the submission was received.
What is the product code of K072375?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.