Cleared Traditional

K843012 - WIREGUIDE OR GUIDEWIRE

K843012 is the FDA 510(k) clearance for WIREGUIDE OR GUIDEWIRE by Medi-Tech, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K843012 · Medi-Tech, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
121d
Days
Class 2
Risk

K843012 is an FDA 510(k) clearance for the WIREGUIDE OR GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Watertown, US). The FDA issued a Cleared decision on November 29, 1984 after a review of 121 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K843012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1984
Decision Date November 29, 1984
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
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 K843012.
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
WHOLEY HI-TORQUE GUIDE WIRES
K852123 · Advanced Cardiovascular Systems, Inc. · Jun 1985
CARDIOVASCULAR SPRING GUIDE WIRE
K834223 · Mallinckrodt Critical Care · Feb 1984
OPEN END SPRING GUIDE
K832607 · C.R. Bard, Inc. · Dec 1983
STAINLESS STEEL GUIDE WIRE
K831839 · Quinton, Inc. · Jul 1983