Cleared Traditional

K860307 - PEEL AWAY & SPLIT SHEATH PERCU CATH INT...

K860307 is an FDA 510(k) clearance for PEEL AWAY & SPLIT SHEATH PERCU CATH INT..., manufactured by Teleflex, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K860307 · Teleflex, Inc. · Cardiovascular device
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May 1986
Decision
112d
Days
Class 2
Risk

K860307 is an FDA 510(k) clearance for the PEEL AWAY & SPLIT SHEATH PERCU CATH INTRODUCER SET. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Teleflex, Inc. (Jeffrey, US). The FDA issued a Cleared decision on May 20, 1986 after a review of 112 days - within the typical 510(k) review window.

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 Teleflex, Inc. devices

FDA 510(k) Submission Details - K860307

510(k) Number K860307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1986
Decision Date May 20, 1986
Days to Decision 112 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 482
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K860307.
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · Quinton, Inc. · Jan 1987
TERUMO RADIFOCUS INTRODUCER KIT
K863139 · Terumo Medical Corp. · Oct 1986
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
K861984 · Universal Medical Instrument Corp. · Aug 1986
CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST
K861082 · Cordis Corp. · May 1986
CATHETER INTRODUCER
K860958 · Target Therapeutics · Apr 1986
PMS PERCUTANEOUS PUNCTURE NEEDLE
K854941 · Professional Medical Services · Apr 1986