Cleared Traditional

K800580 - PERCUTANEOUS CATHETER INTRODUCER

K800580 is an FDA 510(k) clearance for PERCUTANEOUS CATHETER INTRODUCER, manufactured by Alva Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K800580 · Alva Medical, Inc. · Cardiovascular device
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Apr 1980
Decision
19d
Days
Class 2
Risk

K800580 is an FDA 510(k) clearance for the PERCUTANEOUS CATHETER INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Alva Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980 after a review of 19 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 Alva Medical, Inc. devices

FDA 510(k) Submission Details - K800580

510(k) Number K800580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1980
Decision Date April 02, 1980
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
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 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K800580.
THERMODILUTION CATHETER INTRO. KIT
K800619 · Norton Performance Plastics Corp. · Apr 1980
VENOUS M/A INTERNAL JUGULAR KIT
K800620 · Norton Performance Plastics Corp. · Apr 1980
PERCUTANEOUS CATHETER INTRODUCER ADAPTER
K800621 · Norton Performance Plastics Corp. · Apr 1980
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · C.R. Bard, Inc. · Nov 1979
TRANSVENOUS BALLOON CATH. INTRO. KIT
K792130 · Stanco Medical, Inc. · Nov 1979
TEMPORARY TRANSVENOUS PACMKER. ELECTRODE
K792131 · Stanco Medical, Inc. · Nov 1979