Cleared Traditional

K073471 - VANTAGECATH INTRAVASCULAR CATHETER

K073471 is an FDA 510(k) clearance for VANTAGECATH INTRAVASCULAR CATHETER, manufactured by Advantage Medical Device. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K073471 · Advantage Medical Device · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
141d
Days
Class 2
Risk

K073471 is an FDA 510(k) clearance for the VANTAGECATH INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Advantage Medical Device (Laguna Niguel, US). The FDA issued a Cleared decision on April 30, 2008 after a review of 141 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 - K073471

510(k) Number K073471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2007
Decision Date April 30, 2008
Days to Decision 141 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 129d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 473
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K073471.
SURSHIELD SAFETY I.V. CATHETER
K082362 · Terumo Medical Corp. · Sep 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
K081113 · Cook, Inc. · Jul 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K081690 · Cook, Inc. · Jul 2008
ANGIOTECH CVC
K073520 · Angiotech Pharmaceuticals, Inc. · Apr 2008
VASCULAR PATHWAYS RIVS RAPID INTRAVASCULAR CATHETER START SYSTEM
K073241 · Vascular Pathways · Feb 2008
MODIFICATION TO: LATEX-FREE BIONECTOR, MODEL# 896.019, 896.039
K070705 · Vygon Corp. · Nov 2007

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K073471 · VANTAGECATH INTRAVASCULAR CATHETER
Download PDF FDA Summary Advantage Medical Dev…