Cleared Traditional

K920779 - FAST-CATH HEMOSTASIS INTRODUCER

K920779 is an FDA 510(k) clearance for FAST-CATH HEMOSTASIS INTRODUCER, 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 104-day FDA review.

K920779 · Daig Corp. · Cardiovascular device
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Jun 1992
Decision
104d
Days
Class 2
Risk

K920779 is an FDA 510(k) clearance for the FAST-CATH HEMOSTASIS 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 June 3, 1992 after a review of 104 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 - K920779

510(k) Number K920779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date June 03, 1992
Days to Decision 104 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
21d faster than avg
Panel avg: 125d · This submission: 104d
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 K920779.
CATHETER INTRODUCER
K920528 · Boston Scientific Corp · Aug 1992
MORSE HEMOSTATIC CATHETER INTRODUCER SET
K915078 · North American Instrument Corp. · Jun 1992
INTRODUCER CATHETER
K915625 · Interventional Therapeutics Corp. · Jun 1992
GORE TUNNELER, MODIFICATION
K920998 · W.L. Gore & Associates, Inc. · Jun 1992
DAIG FAST CATH TRANSSEPTAL SHEATH INTRODUCER
K920327 · Daig Corp. · Apr 1992
USCI HEMAQUET XT INTRODUCER
K920251 · C.R. Bard, Inc. · Mar 1992