Cook High Volume Infusion Adapter Intravascular Administration Set
FDA 510(k) K991985 · Cook, Inc.
510(k) numberK991985
Submission
- Device name
- Cook High Volume Infusion Adapter Intravascular Administration Set
- Applicant
- Cook, Inc.
Bloomington, IN, US - Received
- June 14, 1999
- Decision date
- August 20, 1999
- 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 Cook High Volume Infusion Adapter Intravascular Administration Set cleared by the FDA?
Cook High Volume Infusion Adapter Intravascular Administration Set (K991985) received a 510(k) decision of Substantially Equivalent on August 20, 1999, 67 days after the submission was received.
What is the product code of K991985?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.