Cleared Traditional

10 AND 12 FRENCH VESSEL DILATORS (K874738) - FDA 510(k) Clearance

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

K874738 · Impra, Inc. · Cardiovascular device
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May 1988
Decision
166d
Days
Class 2
Risk

K874738 is an FDA 510(k) clearance for the 10 AND 12 FRENCH VESSEL DILATORS. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on May 2, 1988 after a review of 166 days - an extended review 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: 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 Impra, Inc. devices

Submission Details

510(k) Number K874738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date May 02, 1988
Days to Decision 166 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 125d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 33
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K874738.
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · Cordis Corp. · Apr 1997
VESSEL DILATOR
K904476 · Datascope Corp. · Dec 1990
SHILEY FEMORAL CANNULAE INTRODUCER KIT
K881073 · Shiley, Inc. · Jun 1988
MODIFICATION OF TISSUE DILATOR
K862288 · Quinton, Inc. · Aug 1986
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · Quinton, Inc. · Jul 1984
8 FRENCH DILATOR 15CM, W/LUER LOCK
K833965 · Quinton, Inc. · Dec 1983