Cleared Traditional

K082023 - REPROCESSED ELECTROPHYSIOLOGY CATHETERS

K082023 is the FDA 510(k) clearance for REPROCESSED ELECTROPHYSIOLOGY CATHETERS by Ascent Healthcare Solutions. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K082023 · Ascent Healthcare Solutions · Cardiovascular device
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Sep 2008
Decision
62d
Days
Class 2
Risk

K082023 is an FDA 510(k) clearance for the REPROCESSED ELECTROPHYSIOLOGY CATHETERS. Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Ascent Healthcare Solutions (Phoenix, US). The FDA issued a Cleared decision on September 16, 2008 after a review of 62 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 Ascent Healthcare Solutions devices

Submission Details

510(k) Number K082023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2008
Decision Date September 16, 2008
Days to Decision 62 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
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K082023.
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K121158 · Sterilmed, Inc. · Aug 2012
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K101789 · Sterilmed, Inc. · Aug 2010
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS
K092158 · Sterilmed, Inc. · Jan 2010
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K061045 · Alliance Medical Corp. · Aug 2006
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K052414 · Alliance Medical Corp. · Nov 2005
REPROCESSED DAIG LIVEWIRE ELECTROPHYSIOLOGY CATHETERS
K052603 · Alliance Medical Corp. · Nov 2005