Cleared Traditional

K951802 - SCIMED ENCORE ADVANTAGE KIT AND THE ESS...

K951802 is the FDA 510(k) clearance for SCIMED ENCORE ADVANTAGE KIT AND THE ESS... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K951802 · Scimed Life Systems, Inc. · Cardiovascular device
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Jul 1995
Decision
93d
Days
Class 2
Risk

K951802 is an FDA 510(k) clearance for the SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on July 21, 1995 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K951802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1995
Decision Date July 21, 1995
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K951802.
CONTRAST INJECTION LINES
K960674 · B.Braun Medical, Inc. · Sep 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
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MEDRAD SPECTRIS MR INJECTOR
K935668 · Medrad, Inc. · Sep 1995
MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE
K934086 · Medrad, Inc. · Jun 1995
MEDRAD CT CUSTOM CONVENIENCE KIT
K933908 · Medrad, Inc. · Feb 1994
MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD
K924116 · Medrad, Inc. · Jan 1993