Cleared Traditional

K083920 - FLOWPICC CATHETER

K083920 is an FDA 510(k) clearance for FLOWPICC CATHETER, manufactured by Vasonova, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K083920 · Vasonova, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
121d
Days
Class 2
Risk

K083920 is an FDA 510(k) clearance for the FLOWPICC CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Vasonova, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 1, 2009 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K083920

510(k) Number K083920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2008
Decision Date May 01, 2009
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 287
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K083920.
BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER
K091670 · Becton, Dickinson & CO · Jul 2009
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50
K091466 · Medcomp · Jun 2009
NMI PICC
K091261 · Navilyst Medical, Inc. · May 2009
PICC (CT RATED AND NON-RATED)
K083873 · Pfm Medical, Inc. · Mar 2009
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN
K083763 · R4 Vascular, Inc. · Mar 2009
FLOWPICC CATHETER
K082481 · Vasonova, Inc. · Dec 2008
K083920 · FLOWPICC CATHETER
Download PDF FDA Summary Vasonova, Inc.