Cleared Traditional

K022823 - VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K022823 · Geister Medizin Technik GmbH · Cardiovascular device
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Jul 2004
Decision
675d
Days
Class 2
Risk

K022823 is an FDA 510(k) clearance for the VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520. Classified as Valvulotome (product code MGZ), Class II - Special Controls.

Submitted by Geister Medizin Technik GmbH (Hot Springs, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 675 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4885 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

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Submission Details

510(k) Number K022823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date July 01, 2004
Days to Decision 675 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
550d slower than avg
Panel avg: 125d · This submission: 675d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MGZ Valvulotome
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4885
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.