Cleared Traditional

K791276 - PERVENOUS LEAD INTRODUCER SYSTEM

K791276 is an FDA 510(k) clearance for PERVENOUS LEAD INTRODUCER SYSTEM, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K791276 · Cordis Corp. · Cardiovascular device
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Jul 1979
Decision
15d
Days
Class 2
Risk

K791276 is an FDA 510(k) clearance for the PERVENOUS LEAD INTRODUCER SYSTEM. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on July 24, 1979 after a review of 15 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 Cordis Corp. devices

FDA 510(k) Submission Details - K791276

510(k) Number K791276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1979
Decision Date July 24, 1979
Days to Decision 15 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
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

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 541
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K791276.
CATHETER GUIDE WIRE
K820699 · Quest Medical, Inc. · Apr 1982
ARROW RADIAL ARTERY CATHETERIZATION SET
K810675 · Arrow Intl., Inc. · Mar 1981
BENZALKONIUM-HEPARIN COATED GUIDEWIRES
K802473 · Medrad, Inc. · Nov 1980
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