Cleared Traditional

K961883 - VERSA-CATH ARTERIAL CATHETER

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

K961883 · Ideas For Medicine, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K961883

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
Combination Product No
PCCP Authorized No
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.

DXE Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K961883.
LMI IRRIGATION CATHETER (IGR)
K972623 · Lucas Medical, Inc. · Nov 1997
LMI THROMBECTOMY CATHETER
K970657 · Lucas Medical, Inc. · Jul 1997
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
VASO-SAFE ARTERIAL EMBOLECTOMY CATHETE
K961716 · Ideas For Medicine, Inc. · Sep 1996
LMI ARTERIAL EMBOLECTOMY CATHETER
K954760 · Lucas Medical, Inc. · Apr 1996