Cleared Traditional

K870374 - PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK

K870374 is an FDA 510(k) clearance for PERCUTANEOUS INTRODUCER W/SIDE PORT 3 W..., 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 48-day FDA review.

K870374 · Daig Corp. · Cardiovascular device
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Mar 1987
Decision
48d
Days
Class 2
Risk

K870374 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on March 18, 1987 after a review of 48 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 - K870374

510(k) Number K870374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1987
Decision Date March 18, 1987
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
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 616
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K870374.
UNIPOLAR ENDOCARDIAL SCREW-IN LEAD, MODEL 1007M
K871208 · Pacesetter Systems · Jun 1987
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER
K871140 · Aries Medical, Inc. · Apr 1987
INTRODUCER, PERCUTANEOUS
K870907 · Med Fusion Systems, Inc. · Apr 1987
ARIES TAPERED SHEATH
K870189 · Aries Medical, Inc. · Mar 1987
MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH
K864705 · Quinton, Inc. · Feb 1987
MODIFIED PEEL-AWAY INTRODUCER SET LINE
K864352 · Quinton, Inc. · Jan 1987