Cleared Traditional

K051043 - VANGUARD REPROCESSED DIAGNOSTIC ELECTRO...

K051043 is an FDA 510(k) clearance for VANGUARD REPROCESSED DIAGNOSTIC ELECTRO..., manufactured by Vanguard Medical Concepts, Inc.. The device is a Class 2 Cardiovascular device with product code NLH cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K051043 · Vanguard Medical Concepts, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
42d
Days
Class 2
Risk

K051043 is an FDA 510(k) clearance for the VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Vanguard Medical Concepts, Inc. (Lakeland, US). The FDA issued a Cleared decision on June 6, 2005 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vanguard Medical Concepts, Inc. devices

FDA 510(k) Submission Details - K051043

510(k) Number K051043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2005
Decision Date June 06, 2005
Days to Decision 42 days
Submission Type Traditional
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
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLH Device Classification - Class 2, Special Controls

Product Code NLH Catheter, Recording, Electrode, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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 - NLH Catheter, Recording, Electrode, Reprocessed

All 62
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K051043.
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K052414 · Alliance Medical Corp. · Nov 2005
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
K052603 · Alliance Medical Corp. · Nov 2005
REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K051220 · Sterilmed, Inc. · Jun 2005
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K050763 · Vanguard Medical Concepts, Inc. · Jun 2005
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K043392 · Alliance Medical Corp. · Mar 2005
REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS
K043393 · Alliance Medical Corp. · Mar 2005