Cleared Traditional

K900207 - EPICARDIA 4000

K900207 is an FDA 510(k) clearance for EPICARDIA 4000, manufactured by Medicomp, Inc.. The device is a Class 2 Cardiovascular device with product code DST cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K900207 · Medicomp, Inc. · Cardiovascular device
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Jul 1990
Decision
196d
Days
Class 2
Risk

K900207 is an FDA 510(k) clearance for the EPICARDIA 4000. Classified as Clip, Vena-cava (product code DST), Class II - Special Controls.

Submitted by Medicomp, Inc. (West Melbourne, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3260 - 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 Medicomp, Inc. devices

FDA 510(k) Submission Details - K900207

510(k) Number K900207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1990
Decision Date July 31, 1990
Days to Decision 196 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DST Device Classification - Class 2, Special Controls

Product Code DST Clip, Vena-cava
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3260
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.