Cleared Special

K170263 - AcuNav Diagnostic Ultrasound Catheter 8F,10F

K170263 is an FDA 510(k) clearance for AcuNav Diagnostic Ultrasound Catheter 8F, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Cardiovascular device with product code OBJ cleared through the Special 510(k) pathway after a 139-day FDA review.

K170263 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
139d
Days
Class 2
Risk

K170263 is an FDA 510(k) clearance for the AcuNav Diagnostic Ultrasound Catheter 8F,10F. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Moutain View, US). The FDA issued a Cleared decision on June 15, 2017 after a review of 139 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K170263

510(k) Number K170263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2017
Decision Date June 15, 2017
Days to Decision 139 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
14d slower than avg
Panel avg: 125d · This submission: 139d
Pathway characteristics
Modification to existing cleared device.

OBJ Device Classification - Class 2, Special Controls

Product Code OBJ Catheter, Ultrasound, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology.
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 - OBJ Catheter, Ultrasound, Intravascular

All 79
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K170263.
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K170263 · AcuNav Diagnostic Ultrasound Catheter 8F,10F
Download PDF FDA Summary Siemens Medical Solut…