Cleared Traditional

K000743 - BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020

K000743 is an FDA 510(k) clearance for BOSTON SCIENTIFIC SCIMED ATLANTIS CORON..., manufactured by Boston Scientific Scimed, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K000743 · Boston Scientific Scimed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
183d
Days
Class 2
Risk

K000743 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Maple Grove, US). The FDA issued a Cleared decision on September 6, 2000 after a review of 183 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 Boston Scientific Scimed, Inc. devices

FDA 510(k) Submission Details - K000743

510(k) Number K000743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2000
Decision Date September 06, 2000
Days to Decision 183 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
58d slower than avg
Panel avg: 125d · This submission: 183d
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 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K000743.
MULTITRACK ANGIOGRAPHIC CATHETER
K003902 · NuMED, Inc. · Jan 2001
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · AngioDynamics, Inc. · Oct 2000
GOLDEN-RULE SCALING CATHETER
K002416 · Medical Device Technologies, Inc. · Sep 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · Cordis Corp. · May 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
K000956 · Boston Scientific Scimed, Inc. · Apr 2000
MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT
K000659 · Merit Medical Systems, Inc. · Mar 2000