Cleared Traditional

K920327 - DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER

K920327 is an FDA 510(k) clearance for DAIG FAST CATH TRANSSEPTAL SHEATH INTRO..., manufactured by Daig Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920327 · Daig Corp. · Cardiovascular device
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Apr 1992
Decision
90d
Days
Class 2
Risk

K920327 is an FDA 510(k) clearance for the DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on April 16, 1992 after a review of 90 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 Daig Corp. devices

FDA 510(k) Submission Details - K920327

510(k) Number K920327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1992
Decision Date April 16, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 618
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K920327.
INTRODUCER CATHETER
K915625 · Interventional Therapeutics Corp. · Jun 1992
FAST-CATH HEMOSTASIS INTRODUCER
K920779 · Daig Corp. · Jun 1992
GORE TUNNELER, MODIFICATION
K920998 · W.L. Gore & Associates, Inc. · Jun 1992
USCI HEMAQUET XT INTRODUCER
K920251 · C.R. Bard, Inc. · Mar 1992
GUIDEWIRE INTRODUCER SET
K915421 · B. Braun of America, Inc. · Feb 1992
USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING
K915553 · C.R. Bard, Inc. · Feb 1992