Cleared Traditional

K843118 - CANNULA INTRODUCER

K843118 is an FDA 510(k) clearance for CANNULA INTRODUCER, manufactured by Cardiovascular Research, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K843118 · Cardiovascular Research, Inc. · Cardiovascular device
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Nov 1984
Decision
97d
Days
Class 2
Risk

K843118 is an FDA 510(k) clearance for the CANNULA INTRODUCER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Cardiovascular Research, Inc. (St Petersburg, US). The FDA issued a Cleared decision on November 13, 1984 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Research, Inc. devices

FDA 510(k) Submission Details - K843118

510(k) Number K843118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1984
Decision Date November 13, 1984
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 K843118.
PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID
K850820 · Universal Medical Instrument Corp. · Apr 1985
PEEL-AWAY INTRODUCER SET
K844693 · Quinton, Inc. · Mar 1985
MEADOX SURGIMED A/S CATHETER SHEATH SYS
K843798 · Meadox Surgimed, Inc. · Dec 1984
MEDTRONIC 6210 PERMANENT LEAD INTRODUC
K842780 · Medtronic Vascular · Aug 1984
PCI W/CATH-SEAL SIDE FLOW FITTING
K842259 · Universal Medical Instrument Corp. · Aug 1984
PERCUTANEOUS CATHETER INTRODUCER SET
K842004 · Aries Medical, Inc. · Jul 1984