Cleared Traditional

K082519 - FINECROSS MG CORONARY MICRO-GUIDE CATHETER

K082519 is an FDA 510(k) clearance for FINECROSS MG CORONARY MICRO-GUIDE CATHETER, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K082519 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
24d
Days
Class 2
Risk

K082519 is an FDA 510(k) clearance for the FINECROSS MG CORONARY MICRO-GUIDE CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on September 26, 2008 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K082519

510(k) Number K082519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date September 26, 2008
Days to Decision 24 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KRA Device Classification - Class 2, Special Controls

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 - KRA Catheter, Continuous Flush

All 130
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K082519.
CROSSCATH SUPPORT CATHTER
K093052 · Cook, Inc. · Dec 2009
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY
K090870 · Micro Therapeutics, Inc. · May 2009
MERIT MICROCATHETER
K082613 · Merit Medical Systems, Inc. · Dec 2008
MIRAFLEX HIGH FLOW MICROCATHETER
K080737 · Cook, Inc. · Aug 2008
ENDOWAVE INFUSION SYSTEM
K073166 · Ekos Corp. · Apr 2008
CXI SUPPORT CATHETER
K072724 · Cook, Inc. · Nov 2007