Cleared Traditional

LOCALMED INFUSION CATHETER (K935349) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935349 · Localmed, Inc. · Cardiovascular device
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Oct 1994
Decision
347d
Days
Class 2
Risk

K935349 is an FDA 510(k) clearance for the LOCALMED INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Localmed, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on October 18, 1994 after a review of 347 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 Localmed, Inc. devices

Submission Details

510(k) Number K935349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1993
Decision Date October 18, 1994
Days to Decision 347 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
222d slower than avg
Panel avg: 125d · This submission: 347d
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 65
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K935349.
INTRAVASCULAR INFUSION DEVICE
K963988 · Boston Scientific Corp · Dec 1996
MICROFERRET CATHETER
K961668 · Cook, Inc. · Nov 1996
EVOLUTION(TM) MICROCATHETER
K945666 · Boston Scientific Corp · Jun 1995
SAFESET RESERVOIR
K932188 · Abbott Laboratories · Oct 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · Baxter Healthcare Corp · Jan 1990