Cleared Traditional

K981788 - SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER

K981788 is the FDA 510(k) clearance for SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K981788 · Scimed Life Systems, Inc. · Cardiovascular device
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Aug 1998
Decision
90d
Days
Class 2
Risk

K981788 is an FDA 510(k) clearance for the SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Maple Grove, US). The FDA issued a Cleared decision on August 18, 1998 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 870.1200 - 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 Life Systems, Inc. devices

Submission Details

510(k) Number K981788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1998
Decision Date August 18, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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 DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 291
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K981788.
CORDIS TEMPO ANGIOGRAPHY CATHETER
K991673 · Cordis Corp. · May 1999
SPYGLASS 5 FR ANGIOGRAPHIC CATHETER
K982299 · Daig Corp. · Oct 1998
ENVY GUIDING CATHETER
K974774 · Cook, Inc. · Oct 1998
SELECTOR DIAGNOSTIC CATHETER
K982077 · Boston Scientific Scimed, Inc. · Aug 1998
HEART CATH TRAY, STERILE, DISPOSABLE
K981441 · Trinity Laboratories, Inc. · Jul 1998
SITESEER ANGIOGRAPHIC CATHETER
K980575 · C.R. Bard, Inc. · May 1998