Cleared Special

K050684 - ATLANTIS PV

K050684 is an FDA 510(k) clearance for ATLANTIS PV, manufactured by Boston Scientific Corp. The device is a Class 2 Radiology device with product code DQO cleared through the Special 510(k) pathway after a 64-day FDA review.

K050684 · Boston Scientific Corp · Radiology device
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May 2005
Decision
64d
Days
Class 2
Risk

K050684 is an FDA 510(k) clearance for the ATLANTIS PV. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Corp (Fremont, US). The FDA issued a Cleared decision on May 20, 2005 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1200 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050684

510(k) Number K050684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2005
Decision Date May 20, 2005
Days to Decision 64 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 Radiology devices follow this clearance model.

Regulatory Peers - DQO Catheter, Intravascular, Diagnostic

All 489
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K050684.
IMAGER II ANGIOGRAPHIC CATHETER
K050863 · Boston Scientific Corp · Sep 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K051395 · Vascular Solutions, Inc. · Jun 2005
MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER
K050371 · Medrad, Inc. · Jun 2005
LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER
K050168 · Vascular Solutions, Inc. · May 2005
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
K050577 · Boston Scientific Corp · Mar 2005
METRICATH SYSTEM
K042685 · Angiometrx, Inc. · Nov 2004
K050684 · ATLANTIS PV
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