Scimed Encore(Tm) Advantage Kit/Essentials Kit
FDA 510(k) K925608 · Scimed Life Systems, Inc.
510(k) numberK925608
Submission
- Device name
- Scimed Encore(Tm) Advantage Kit/Essentials Kit
- Applicant
- Scimed Life Systems, Inc.
Maple Grove, MN, US - Received
- November 5, 1992
- Decision date
- June 16, 1993
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MFY – Endothelial Cell Harvesting Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4075
- Specialty
- Cardiovascular
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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Questions and answers
When was Scimed Encore(Tm) Advantage Kit/Essentials Kit cleared by the FDA?
Scimed Encore(Tm) Advantage Kit/Essentials Kit (K925608) received a 510(k) decision of Unknown on June 16, 1993, 223 days after the submission was received.
What is the product code of K925608?
The FDA product code is MFY – Endothelial Cell Harvesting Kit, a Class II (moderate risk) device regulated under 21 CFR 870.4075.