Cleared Traditional

K893658 - PERCUTANEOUS INTRODUCER

K893658 is an FDA 510(k) clearance for PERCUTANEOUS INTRODUCER, manufactured by Medamicus, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K893658 · Medamicus, Inc. · Cardiovascular device
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Aug 1989
Decision
80d
Days
Class 2
Risk

K893658 is an FDA 510(k) clearance for the PERCUTANEOUS INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 3, 1989 after a review of 80 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 Medamicus, Inc. devices

FDA 510(k) Submission Details - K893658

510(k) Number K893658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date August 03, 1989
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
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 535
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K893658.
MODIFIED LABELING TO PERMANENT LEAD INTRODUCER
K894431 · Daig Corp. · 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
INTRODUCER FOR PTCA GUIDING CATHETERS
K891022 · Argon Medical Corp. · May 1989
HEMOSTASIS VALVE, WITH OR WITHOUT SIDE PORT
K890277 · Oscor Medical Corp. · Mar 1989
DAIG OBTURATOR, CATHETER INTRODUCER
K884494 · Daig Corp. · Feb 1989