Cleared Special

K010707 - ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975

K010707 is an FDA 510(k) clearance for ATLANTIS SR PLUS CORONARY IMAGING CATHETER, manufactured by Boston Scientific, Target. The device is a Class 2 Radiology device with product code DQO cleared through the Special 510(k) pathway after a 20-day FDA review.

K010707 · Boston Scientific, Target · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
20d
Days
Class 2
Risk

K010707 is an FDA 510(k) clearance for the ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on March 29, 2001 after a review of 20 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 - K010707

510(k) Number K010707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2001
Decision Date March 29, 2001
Days to Decision 20 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
87d faster than avg
Panel avg: 107d · This submission: 20d
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 438
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K010707.
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · Concentric Medical, Inc. · May 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217 · Abbott Laboratories · May 2001
CARDIAC FUNCTION LABORATORY
K003020 · Cd Leycom BV · May 2001
COOK PRESSURE MONITORING CATHETER
K002254 · Cook, Inc. · Mar 2001
TRAK BACK II
K003938 · Jomed, Inc. · Jan 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · AngioDynamics, Inc. · Jan 2001
K010707 · ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
Download PDF FDA Summary Boston Scientific, Ta…