Cleared Traditional

K050962 - MERIT PRELUDE SHEATH INTRODUCER

K050962 is the FDA 510(k) clearance for MERIT PRELUDE SHEATH INTRODUCER by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K050962 · Merit Medical Systems, Inc. · Cardiovascular device
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May 2005
Decision
18d
Days
Class 2
Risk

K050962 is an FDA 510(k) clearance for the MERIT PRELUDE SHEATH INTRODUCER. 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 May 6, 2005 after a review of 18 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K050962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date May 06, 2005
Days to Decision 18 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Kema Quality B.V.
J.A. VAN VUGT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K050962.
MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
K091584 · Merit Medical Systems, Inc. · Oct 2009
PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
K073035 · Merit Medical Systems, Inc. · Nov 2007
PRELUDE SHEATH INTRODUCER
K070159 · Merit Medical Systems, Inc. · Jun 2007
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · Uresil Corp. · Apr 1998
COAXIAL DILATOR SET
K974640 · Boston Scientific Corp · Mar 1998