Lifeshield Luer Activated Valve Male Adapter Plug
FDA 510(k) K953584 · Abbott Laboratories
510(k) numberK953584
Submission
- Device name
- Lifeshield Luer Activated Valve Male Adapter Plug
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 1, 1995
- Decision date
- October 24, 1995
- 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 Lifeshield Luer Activated Valve Male Adapter Plug cleared by the FDA?
Lifeshield Luer Activated Valve Male Adapter Plug (K953584) received a 510(k) decision of Substantially Equivalent on October 24, 1995, 84 days after the submission was received.
What is the product code of K953584?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.