Cleared Traditional

LEAD INTRODUCER SET (K790882) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K790882 · Introstat · Cardiovascular device
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Jun 1979
Decision
34d
Days
Class 2
Risk

K790882 is an FDA 510(k) clearance for the LEAD INTRODUCER SET. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Introstat (Mchenry, US). The FDA issued a Cleared decision on June 11, 1979 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 Introstat devices

Submission Details

510(k) Number K790882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1979
Decision Date June 11, 1979
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 252
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K790882.
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 1983
PERVENOUS LEAD INTRODUCER SYSTEM
K791276 · Cordis Corp. · Jul 1979
MOVABLE CORE SAFETY GUIDE
K790258 · Cordis Corp. · Feb 1979
VARIABLE STIFFNESS WIRE GUIDE
K781393 · Cook, Inc. · Oct 1978
SAFETY SPRING GUIDES, TEFLON COATED
K780438 · C.R. Bard, Inc. · Jun 1978