Cleared Traditional

K840763 - SILVERTORQUE CARDIAC CATHETERS

K840763 is an FDA 510(k) clearance for SILVERTORQUE CARDIAC CATHETERS, manufactured by Surgimed Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K840763 · Surgimed Corp. · Cardiovascular device
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Jun 1984
Decision
111d
Days
Class 2
Risk

K840763 is an FDA 510(k) clearance for the SILVERTORQUE CARDIAC CATHETERS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Surgimed Corp. (Mchenry, US). The FDA issued a Cleared decision on June 13, 1984 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Surgimed Corp. devices

FDA 510(k) Submission Details - K840763

510(k) Number K840763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date June 13, 1984
Days to Decision 111 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 125d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 370
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K840763.
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · American Edwards Laboratories · Aug 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799 · American Edwards Laboratories · Aug 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · Advanced Cardiovascular Systems, Inc. · Jul 1984
ELECATH HEPARIN-COATED CATHETERS
K841615 · Electro-Catheter Corp. · Jun 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · American Edwards Laboratories · Feb 1984
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983