Cleared Special

K073035 - PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS

K073035 is the FDA 510(k) clearance for PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Special 510(k) pathway after a 22-day FDA review.

K073035 · Merit Medical Systems, Inc. · Cardiovascular device
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Nov 2007
Decision
22d
Days
Class 2
Risk

K073035 is an FDA 510(k) clearance for the PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 20, 2007 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K073035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2007
Decision Date November 20, 2007
Days to Decision 22 days
Submission Type Special
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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 43
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K073035.
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