Cleared Traditional

K854511 - ELECATH PERCUTANEOUS LEFT ATRIAL CANNUL...

K854511 is the FDA 510(k) clearance for ELECATH PERCUTANEOUS LEFT ATRIAL CANNUL... by Electro-Catheter Corp.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K854511 · Electro-Catheter Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1986
Decision
90d
Days
Class 2
Risk

K854511 is an FDA 510(k) clearance for the ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Rahway, US). The FDA issued a Cleared decision on February 10, 1986 after a review of 90 days - within the typical 510(k) review window.

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: 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 Electro-Catheter Corp. devices

Submission Details

510(k) Number K854511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date February 10, 1986
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 428
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K854511.
GUIDED WIRE TORQUER
K860840 · Target Therapeutics · Apr 1986
ACS HI-TORQUE TAPERED DIAMETER GUIDE WIRES
K854830 · Advanced Cardiovascular Systems, Inc. · Mar 1986
(.O38) HI-TORQUE GUIDE WIRES
K860533 · Target Therapeutics · Mar 1986
GUIDE WIRE
K853999 · Target Therapeutics · Nov 1985
WHOLEY HI-TORQUE GUIDE WIRES
K852354 · Advanced Cardiovascular Systems, Inc. · Jul 1985
MODIFICATIONS TO ACS CORONARY GUIDING CATHETER W/T
K851574 · Advanced Cardiovascular Systems, Inc. · Jun 1985