Cleared Traditional

K971619 - MICROFUSE MEMBRANE INFUSION CATHETER

K971619 is the FDA 510(k) clearance for MICROFUSE MEMBRANE INFUSION CATHETER by E-Med Corp.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K971619 · E-Med Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
302d
Days
Class 2
Risk

K971619 is an FDA 510(k) clearance for the MICROFUSE MEMBRANE INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by E-Med Corp. (Saint Paul, US). The FDA issued a Cleared decision on February 27, 1998 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 E-Med Corp. devices

Submission Details

510(k) Number K971619 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1997
Decision Date February 27, 1998
Days to Decision 302 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
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - KRA Catheter, Continuous Flush

All 129
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K971619.
1 MASS TRANSIT INFUSION CATHETER, 1 VARIOUS
K983003 · Cordis Neurovascular, Inc. · Sep 1998
EASY RIDER MICRO CATHETER
K974473 · Micro Therapeutics, Inc. · Jun 1998
FLOW RIDER FLOW DIRECTED MICRO CATHETER
K980104 · Micro Therapeutics, Inc. · Apr 1998
CES MASSTRANSIT INFUSION CATHETER
K974222 · Cordis Neurovascular, Inc. · Feb 1998
RENEGADE FIBER BRAIDED MICROCATHETER
K973645 · Boston Scientific Corp · Nov 1997
TRANSIT/RAPIDTRANSIT/SPEEDSTER/PROWLER INFUSION CATHETER
K972518 · Cordis Neurovascular, Inc. · Nov 1997