Cleared Traditional

K030187 - REPROCESSED ELECTROPHYSIOLOGY CATHETER

K030187 is an FDA 510(k) clearance for REPROCESSED ELECTROPHYSIOLOGY CATHETER, manufactured by Alliance Medical, Inc.. The device is a Class 2 Cardiovascular device with product code NLH cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K030187 · Alliance Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
246d
Days
Class 2
Risk

K030187 is an FDA 510(k) clearance for the REPROCESSED ELECTROPHYSIOLOGY CATHETER. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Alliance Medical, Inc. (Phoenix, US). The FDA issued a Cleared decision on September 24, 2003 after a review of 246 days - an extended review 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: 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 Alliance Medical, Inc. devices

FDA 510(k) Submission Details - K030187

510(k) Number K030187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2003
Decision Date September 24, 2003
Days to Decision 246 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
121d slower than avg
Panel avg: 125d · This submission: 246d
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 68
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K030187.
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K042074 · Vanguard Medical Concepts, Inc. · Mar 2005
STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER
K043513 · Sterilmed, Inc. · Mar 2005
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030279 · Alliance Medical Corp. · Oct 2003
ELECTROPHYSIOLOGY CATHETER
K030109 · Alliance Medical Corp. · Aug 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030026 · Alliance Medical Corp. · May 2003
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
K030114 · Vanguard Medical Concepts, Inc. · Mar 2003