Cleared Traditional

K952345 - MEDI-TECH PLATFORM GUIDE CATHETER

K952345 is the FDA 510(k) clearance for MEDI-TECH PLATFORM GUIDE CATHETER by Medi-Tech, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K952345 · Medi-Tech, Inc. · Cardiovascular device
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Aug 1995
Decision
90d
Days
Class 2
Risk

K952345 is an FDA 510(k) clearance for the MEDI-TECH PLATFORM GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medi-Tech, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 17, 1995 after a review of 90 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 Medi-Tech, Inc. devices

Submission Details

510(k) Number K952345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1995
Decision Date August 17, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K952345.
ACS TOURGIDE GUIDING CATHETER
K953987 · Advanced Cardiovascular Systems, Inc. · Dec 1995
FASGUIDE
K951159 · Target Therapeutics · Sep 1995
SCIMED TRIGUIDE GUIDE CATHETERS
K953515 · Scimed Life Systems, Inc. · Sep 1995
ACS POWERBASE GUILDING CATHETER
K952205 · Advanced Cardiovascular Systems, Inc. · Aug 1995
CORDIS BRITE TIP, ENVOY GUIDING CATHETER
K952185 · Cordis Corp. · Aug 1995
SCIMED(R) TRIDUIGE(R) GUIDE CATHETERS
K946204 · Scimed Life Systems, Inc. · Mar 1995