Cleared Traditional

FLOWPICC STYLET (K081625) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K081625 · Vasonova, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
108d
Days
Class 2
Risk

K081625 is an FDA 510(k) clearance for the FLOWPICC STYLET. Classified as Catheter, Ultrasound, Intravascular (product code OBJ), Class II - Special Controls.

Submitted by Vasonova, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 26, 2008 after a review of 108 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vasonova, Inc. devices

Submission Details

510(k) Number K081625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2008
Decision Date September 26, 2008
Days to Decision 108 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 77
Devices cleared under the same product code (OBJ) and FDA review panel - the closest regulatory comparables to K081625.
Novasight Hybrid System
K252945 · Conavi Medical, Inc. · Apr 2026
OptiCross Coronary Imaging Catheter (H749518110)
K260816 · Boston Scientific · Apr 2026
Visions® PV .014P RX Digital IVUS Catheter
K253399 · Volcano Corporation (Dba Philips Image Guided Therapy Device · Oct 2025
XC11 ICE System, USA
K250955 · Yorlabs, Inc. · Oct 2025
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
K250913 · Jiangsu Tingsn Technology Co., Ltd. · Jul 2025
ViewFlex™ Xtra ICE Catheter
K251211 · Abbott Medical · May 2025