Lifeshield Primary I.V. Set with Backcheck Valve
FDA 510(k) K971293 · Abbott Mfg., Inc.
510(k) numberK971293
Submission
- Device name
- Lifeshield Primary I.V. Set with Backcheck Valve
- Applicant
- Abbott Mfg., Inc.
Abbott Park, IL, US - Received
- April 7, 1997
- Decision date
- June 27, 1997
- 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 Primary I.V. Set with Backcheck Valve cleared by the FDA?
Lifeshield Primary I.V. Set with Backcheck Valve (K971293) received a 510(k) decision of Substantially Equivalent on June 27, 1997, 81 days after the submission was received.
What is the product code of K971293?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.