Cleared Traditional

K961883 - VERSA-CATH ARTERIAL CATHETER

K961883 is the FDA 510(k) clearance for VERSA-CATH ARTERIAL CATHETER by Ideas For Medicine, Inc.. It is a Class 2 Cardiovascular device (product code DXE) cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K961883 · Ideas For Medicine, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 1997
Decision
243d
Days
Class 2
Risk

K961883 is an FDA 510(k) clearance for the VERSA-CATH ARTERIAL CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Ideas For Medicine, Inc. (Pinellas Park, US). The FDA issued a Cleared decision on January 13, 1997 after a review of 243 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Ideas For Medicine, Inc. devices

Submission Details

510(k) Number K961883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1996
Decision Date January 13, 1997
Days to Decision 243 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
118d slower than avg
Panel avg: 125d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 35
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K961883.
DCAT EMBOLECTOMY CATHETER SYSTEM
K971314 · AngioDynamics, Inc. · Mar 1998
LATIS GRAFT CLEANING CATHETER
K973465 · Applied Medical Resources · Feb 1998
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993