Cleared Traditional

K911883 - DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER

K911883 is an FDA 510(k) clearance for DAIG FAST CATH(TM) TRANSSEPTAL SHEATH I..., manufactured by Diag Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K911883 · Diag Corp. · Cardiovascular device
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Nov 1991
Decision
214d
Days
Class 2
Risk

K911883 is an FDA 510(k) clearance for the DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Diag Corp. (Minnetonka, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 214 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 Diag Corp. devices

FDA 510(k) Submission Details - K911883

510(k) Number K911883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date November 29, 1991
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 627
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K911883.
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · C.R. Bard, Inc. · Feb 1992
GESCO PER-Q-CATH CATHETER INTRODUCER
K915167 · Gesco Intl., Inc. · Jan 1992
SOS BLOODLESS NEEDLE
K914330 · E-Z-Em, Inc. · Dec 1991
CORDIS OBTURATOR
K914352 · Cordis Corp. · Nov 1991
THE BIG EASY Y-ADAPTER
K914046 · Microvena Corp. · Nov 1991
DAIG FAST CATH(TM) INTRODUCER, MODIFICATION
K914090 · Daig Corp. · Oct 1991