Cleared Traditional

PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK (K910861) - FDA 510(k) Clearance

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

K910861 · Daig Corp. · Cardiovascular device
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May 1991
Decision
81d
Days
Class 2
Risk

K910861 is an FDA 510(k) clearance for the PERCUTANEOUS INTROD W/SIDEPORT/THREE-WAY STOPCOCK. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on May 7, 1991 after a review of 81 days - a notably fast clearance 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: 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 Daig Corp. devices

Submission Details

510(k) Number K910861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1991
Decision Date May 07, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
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 229
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K910861.
CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE
K911794 · Cordis Corp. · Jul 1991
MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
K911236 · Medtronic Vascular · Jun 1991
CORDIS PEEL-AWAY INSERTION TOOL
K910688 · Cordis Corp. · May 1991
ENTREE SHEATH INTRODUCER SYSTEM
K904475 · Cordis Corp. · Apr 1991
MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S)
K900515 · Medtronic Vascular · Aug 1990
USCI(R) ACCESS(TM) INTRODUCER SET
K901452 · C.R. Bard, Inc. · May 1990