Deseret Positional Suture Wing
FDA 510(k) K915495 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK915495
Submission
- Device name
- Deseret Positional Suture Wing
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Sandy, UT, US - Received
- December 9, 1991
- Decision date
- April 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KMK – Device, Intravascular Catheter Securement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5210
- Specialty
- General Hospital
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Questions and answers
When was Deseret Positional Suture Wing cleared by the FDA?
Deseret Positional Suture Wing (K915495) received a 510(k) decision of Substantially Equivalent on April 6, 1992, 119 days after the submission was received.
What is the product code of K915495?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.