Cleared Traditional

K864118 - MEDI-TECH SELECTIVE TORQUE CATHETER

K864118 is the FDA 510(k) clearance for MEDI-TECH SELECTIVE TORQUE CATHETER by Medi-Tech, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K864118 · Medi-Tech, Inc. · Cardiovascular device
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Apr 1987
Decision
170d
Days
Class 2
Risk

K864118 is an FDA 510(k) clearance for the MEDI-TECH SELECTIVE TORQUE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Watertown, US). The FDA issued a Cleared decision on April 9, 1987 after a review of 170 days - an extended review cycle.

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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K864118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date April 09, 1987
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
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 484
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K864118.
J-CATH, GISH MODEL NO. JVAC-XXXX
K863790 · Gish Biomedical, Inc. · Jun 1987
ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER
K871425 · Advanced Cardiovascular Systems, Inc. · May 1987
CENTRAL VENOUS CATHETER
K870075 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
K870675 · Quinton, Inc. · Apr 1987
VEIN VALVE CUTTER
K862724 · American Edwards Laboratories · Jan 1987
TRACKER INFUSION CATHETER
K862117 · Target Therapeutics · Oct 1986