FDA 510(k)

SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT

K-Number: K951802 · 1995-07-21

Decision Date1995-07-21

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT is the device name listed in this FDA 510(k) record. The listed applicant is Scimed Life Systems, Inc.. It received FDA 510(k) clearance on 1995-07-21 under 510(k) number K951802. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT?

SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT is a medical device that received FDA 510(k) clearance on 1995-07-21. The listed applicant is Scimed Life Systems, Inc.. The 510(k) number is K951802.

When did SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT receive FDA 510(k) clearance?

SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT received FDA 510(k) clearance on 1995-07-21, under 510(k) number K951802.

Who is the listed applicant for SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT?

The FDA 510(k) record lists Scimed Life Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT?

The FDA product code for SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT is DXT.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.