Cleared Traditional

K895437 - SCIMED CORONARY GUIDING CATHETER

K895437 is an FDA 510(k) clearance for SCIMED CORONARY GUIDING CATHETER, manufactured by Scimed Life Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K895437 · Scimed Life Systems, Inc. · Cardiovascular device
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Jun 1990
Decision
293d
Days
Class 2
Risk

K895437 is an FDA 510(k) clearance for the SCIMED CORONARY GUIDING 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 June 28, 1990 after a review of 293 days - an extended review cycle.

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

FDA 510(k) Submission Details - K895437

510(k) Number K895437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1989
Decision Date June 28, 1990
Days to Decision 293 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 125d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 405
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K895437.
ARTERIAL BLOOD SAMPLING KIT
K902771 · Medex, Inc. · Nov 1990
SOFTOUCH GUIDING CATHETER
K902953 · Mallinckrodt Medical · Sep 1990
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
K901691 · Cardiovascular Imaging Systems, Inc. · Jul 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · C.R. Bard, Inc. · Apr 1990
SONICATH(TM) 5 F
K895542 · Boston Scientific Corp · Apr 1990
CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990