Cleared Traditional

K840762 - SILVERTORQUE CEREBRAL CATHETER

K840762 is the FDA 510(k) clearance for SILVERTORQUE CEREBRAL CATHETER by Surgimed Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K840762 · Surgimed Corp. · Cardiovascular device
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Jul 1984
Decision
141d
Days
Class 2
Risk

K840762 is an FDA 510(k) clearance for the SILVERTORQUE CEREBRAL 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 July 13, 1984 after a review of 141 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

Submission Details

510(k) Number K840762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date July 13, 1984
Days to Decision 141 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 slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 483
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K840762.
ARROW-JOHANS ECG ADAPTOR
K843263 · Arrow Intl., Inc. · Sep 1984
CARDIAC SUPPLY TRAY
K842645 · Deroyal Industries, Inc. · Aug 1984
MULTIPRO CATHETER
K841797 · Shiley, Inc. · Aug 1984
RAAF DUAL LUMEN CATHETER
K842176 · Quinton, Inc. · Jul 1984
CENTRAL VENOUS ACCESS CATHETER CVAC-XX
K841587 · Gish Biomedical, Inc. · Jun 1984
RIGHT CORONARY GUIDING CATHETER
K833801 · Advanced Cardiovascular Systems, Inc. · Mar 1984