Cleared Traditional

K894431 - MODIFIED LABELING TO PERMANENT LEAD INTRODUCER

K894431 is an FDA 510(k) clearance for MODIFIED LABELING TO PERMANENT LEAD INT..., 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 51-day FDA review.

K894431 · Daig Corp. · Cardiovascular device
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Sep 1989
Decision
51d
Days
Class 2
Risk

K894431 is an FDA 510(k) clearance for the MODIFIED LABELING TO PERMANENT LEAD 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 September 6, 1989 after a review of 51 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

FDA 510(k) Submission Details - K894431

510(k) Number K894431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1989
Decision Date September 06, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K894431.
OBTURATOR
K894157 · Argon Medical Corp. · Sep 1989
DAIG PERCUTANEOUS CATHETER INTRO. & REMOVABLE HEMO
K894343 · Daig Corp. · Sep 1989
CATHETER INTRODUCER SHEATH
K890766 · Applied Vascular Devices, Inc. · Sep 1989
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
K885179 · Baxter Healthcare Corp · Aug 1989
MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY
K894430 · Daig Corp. · Aug 1989
PERCUTANEOUS INTRODUCER
K893658 · Medamicus, Inc. · Aug 1989