Arrow High Flow Fluid Adminsitration Set W/Blood Filter & Extension Set
FDA 510(k) K953746 · Arrow Intl., Inc.
510(k) numberK953746
Submission
- Device name
- Arrow High Flow Fluid Adminsitration Set W/Blood Filter & Extension Set
- Applicant
- Arrow Intl., Inc.
Reading, PA, US - Received
- August 10, 1995
- Decision date
- January 26, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Arrow High Flow Fluid Adminsitration Set W/Blood Filter & Extension Set cleared by the FDA?
Arrow High Flow Fluid Adminsitration Set W/Blood Filter & Extension Set (K953746) received a 510(k) decision of Substantially Equivalent on January 26, 1996, 169 days after the submission was received.
What is the product code of K953746?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.