Cleared Special

K050577 - ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

K050577 is an FDA 510(k) clearance for ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Special 510(k) pathway after a 23-day FDA review.

K050577 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
23d
Days
Class 2
Risk

K050577 is an FDA 510(k) clearance for the ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014. 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 March 30, 2005 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - the FDA cardiovascular device 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.

View all Boston Scientific Corp devices

FDA 510(k) Submission Details - K050577

510(k) Number K050577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2005
Decision Date March 30, 2005
Days to Decision 23 days
Submission Type Special
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
102d faster than avg
Panel avg: 125d · This submission: 23d
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 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 K050577.
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K041123 · Kerberos Proximal Solutions, Inc. · Aug 2004