Reprocessed Kendall SCD Express Foot Cuff
FDA 510(k) K163055 · Covidien
510(k) numberK163055
Submission
- Device name
- Reprocessed Kendall SCD Express Foot Cuff
- Applicant
- Covidien
Mansfield, MA, US - Received
- November 1, 2016
- Decision date
- December 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
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Questions and answers
When was Reprocessed Kendall SCD Express Foot Cuff cleared by the FDA?
Reprocessed Kendall SCD Express Foot Cuff (K163055) received a 510(k) decision of Substantially Equivalent on December 23, 2016, 52 days after the submission was received.
What is the product code of K163055?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.