Cleared Traditional

K073200 - GANDRAS INTRAVASCULAR CATHETER

K073200 is the FDA 510(k) clearance for GANDRAS INTRAVASCULAR CATHETER by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K073200 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
80d
Days
Class 2
Risk

K073200 is an FDA 510(k) clearance for the GANDRAS INTRAVASCULAR CATHETER, MODELS 5580, 5581 AND 5582. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 1, 2008 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Vascular Solutions, Inc. devices

Submission Details

510(k) Number K073200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date February 01, 2008
Days to Decision 80 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
45d faster than avg
Panel avg: 125d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 269
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K073200.
GREBSET MICRO-INTRODUCER KIT, MODELS 7950, 7951
K081846 · Vascular Solutions, Inc. · Jan 2009
RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER
K082736 · Terumo Medical Corp. · Sep 2008
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905
K073585 · Vascular Solutions, Inc. · Apr 2008
MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
K072796 · Concentric Medical, Inc. · Dec 2007
DYE MANAGEMENT SYSTEM
K063784 · Icu Medical, Inc. · Apr 2007
TWIN-PASS .023 DUAL ACCESS CATHETER, MODEL 5230
K062877 · Vascular Solutions, Inc. · Jan 2007