Cleared Traditional

K914979 - EDM INFUSION CATHETER

K914979 is an FDA 510(k) clearance for EDM INFUSION CATHETER, manufactured by Peripheral Systems Group. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K914979 · Peripheral Systems Group · Cardiovascular device
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Sep 1992
Decision
315d
Days
Class 2
Risk

K914979 is an FDA 510(k) clearance for the EDM(R) INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Peripheral Systems Group (Mountain View, US). The FDA issued a Cleared decision on September 16, 1992 after a review of 315 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 Peripheral Systems Group devices

FDA 510(k) Submission Details - K914979

510(k) Number K914979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1991
Decision Date September 16, 1992
Days to Decision 315 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 125d · This submission: 315d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

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 K914979.
SELECTIVE INFUSION II CATHETER
K914751 · Advanced Cardiovascular Systems, Inc. · May 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993
MAGIC INFUSION CATHETER
K923368 · Target Therapeutics · Apr 1993
E-Z-EM PULSED INFUSION SYSTEM
K905447 · E-Z-Em, Inc. · Apr 1991
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · Baxter Healthcare Corp · Jan 1990
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K885281 · Baxter Healthcare Corp · Mar 1989