Cleared Traditional

K130873 - VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM

Also marketed or referenced as:
VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM VWING VASCULAR NEEDLE GUIDE, 8MM X 07M

K130873 is an FDA 510(k) clearance for VWING VASCULAR NEEDLE GUIDE, manufactured by Vital Access. The device is a Class 2 Gastroenterology & Urology device with product code PFH cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K130873 · Vital Access · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
168d
Days
Class 2
Risk

K130873 is an FDA 510(k) clearance for the VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM. Classified as Venous Window Needle Guide (product code PFH), Class II - Special Controls.

Submitted by Vital Access (Salt Lake City, US). The FDA issued a Cleared decision on September 13, 2013 after a review of 168 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vital Access devices

FDA 510(k) Submission Details - K130873

510(k) Number K130873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2013
Decision Date September 13, 2013
Days to Decision 168 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 131d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

PFH Device Classification - Class 2, Special Controls

Product Code PFH Venous Window Needle Guide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition For Use As An Access Device Accessory On Arteriovenous Fistulas (avf) For Hemodialysis Procedures Using A Constant Site Or Buttonhole Method Of Needle Insertion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01471041 Completed Interventional Industry-sponsored

Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae

Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

54
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied End Stage Renal Disease; AV Fistula; Kidney Failure
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Mark Crawford, BA
Sponsor Vital Access Corp. (industry)
Started 2011-12-01 → Primary completion 2013-03-01 → Completed 2013-06-01
Primary outcome
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
Secondary outcome
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
View full study on ClinicalTrials.gov