Cleared Traditional

SCIMED(R) COURIER GUIDE CATHETER (K946272) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K946272 · Scimed Peripheral Interventions · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
115d
Days
Class 2
Risk

K946272 is an FDA 510(k) clearance for the SCIMED(R) COURIER GUIDE CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Scimed Peripheral Interventions (Maple Grove, US). The FDA issued a Cleared decision on April 17, 1995 after a review of 115 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 Scimed Peripheral Interventions devices

Submission Details

510(k) Number K946272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date April 17, 1995
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
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 313
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K946272.
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K962830 · Cordis Corp. · Oct 1996
CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS
K962362 · Cordis Corp. · Aug 1996
CORDIS BRITE TIP, ENVOY GUIDING CATHETER
K952185 · Cordis Corp. · Aug 1995
GUIDING CATHETER
K930476 · Boston Scientific Corp · Feb 1994
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019 · C.R. Bard, Inc. · Sep 1993
CORDIS 9 F GUIDING CATHETER
K925131 · Cordis Corp. · May 1993