Cleared Traditional

INTROPEEL V (K931218) - FDA 510(k) Clearance

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

K931218 · Menlo Care, Inc. · Cardiovascular device
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Sep 1993
Decision
196d
Days
Class 2
Risk

K931218 is an FDA 510(k) clearance for the INTROPEEL V. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on September 22, 1993 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Menlo Care, Inc. devices

Submission Details

510(k) Number K931218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1993
Decision Date September 22, 1993
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 217
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K931218.
MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM
K952828 · Boston Scientific Corp · Aug 1995
CORDIS INTRODUCING CATHETER
K945524 · Cordis Corp. · Apr 1995
CORDIS AVANTI CATHETER SHEATH INTRODUCER
K945616 · Cordis Corp. · Mar 1995
CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992