Cleared Traditional

K840761 - SILVERTORQUE VISCERAL CATHETER

K840761 is an FDA 510(k) clearance for SILVERTORQUE VISCERAL CATHETER, manufactured by Surgimed Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K840761 · Surgimed Corp. · Cardiovascular device
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Jun 1984
Decision
109d
Days
Class 2
Risk

K840761 is an FDA 510(k) clearance for the SILVERTORQUE VISCERAL CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Surgimed Corp. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 - K840761

510(k) Number K840761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date June 11, 1984
Days to Decision 109 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 667
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K840761.
CENTRAL VENOUS CATHETER W/BIG-GARD
K841828 · Norton Performance Plastics Corp. · Jul 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
CENTRAL VENOUS ACCESS CATHETER CVAC-XX
K841587 · Gish Biomedical, Inc. · Jun 1984
VAS-CATH DSA CATHETER/TRAY
K834232 · Vas-Cath of Canada , Ltd. · Apr 1984
MICROFUSE INTRAVENOUS CATHETER SET
K840240 · Norton Performance Plastics Corp. · Apr 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · Advanced Cardiovascular Systems, Inc. · Mar 1984