Cleared Traditional

K911883 - DAIG FAST CATH(TM) TRANSSEPTAL SHEATH I...

K911883 is the FDA 510(k) clearance for DAIG FAST CATH(TM) TRANSSEPTAL SHEATH I... by Diag Corp.. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 402
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K911883.
USCI HEMAQUET XT INTRODUCER
K920251 · C.R. Bard, Inc. · Mar 1992
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · C.R. Bard, Inc. · Feb 1992
SOS BLOODLESS NEEDLE
K914330 · E-Z-Em, Inc. · Dec 1991
CORDIS OBTURATOR
K914352 · Cordis Corp. · Nov 1991
DAIG FAST CATH(TM) INTRODUCER, MODIFICATION
K914090 · Daig Corp. · Oct 1991
CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL
K913801 · Cordis Corp. · Oct 1991