Cleared Special

K022860 - ATLANTIS PV IMAGING CATHETER, MODEL 36456

K022860 is an FDA 510(k) clearance for ATLANTIS PV IMAGING CATHETER, manufactured by Boston Scientific, Target. The device is a Class 2 Radiology device with product code ITX cleared through the Special 510(k) pathway after a 85-day FDA review.

K022860 · Boston Scientific, Target · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
85d
Days
Class 2
Risk

K022860 is an FDA 510(k) clearance for the ATLANTIS PV IMAGING CATHETER, MODEL 36456. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on November 21, 2002 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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 - K022860

510(k) Number K022860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2002
Decision Date November 21, 2002
Days to Decision 85 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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 - ITX Transducer, Ultrasonic, Diagnostic

All 380
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K022860 · ATLANTIS PV IMAGING CATHETER, MODEL 36456
Download PDF FDA Summary Boston Scientific, Ta…