Cleared Traditional

K914751 - SELECTIVE INFUSION II CATHETER

K914751 is the FDA 510(k) clearance for SELECTIVE INFUSION II CATHETER by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code KRA) cleared through the Traditional 510(k) pathway after a 580-day FDA review.

K914751 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
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May 1993
Decision
580d
Days
Class 2
Risk

K914751 is an FDA 510(k) clearance for the SELECTIVE INFUSION II CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Santa Clara, US). The FDA issued a Cleared decision on May 24, 1993 after a review of 580 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K914751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1991
Decision Date May 24, 1993
Days to Decision 580 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
455d slower than avg
Panel avg: 125d · This submission: 580d
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 127
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K914751.
SCIMED(R) DISPATCH(TM) CORONARY INFUSION CATHETER
K932616 · Scimed Life Systems, Inc. · Dec 1993
SAFESET RESERVOIR
K932188 · Abbott Laboratories · Oct 1993
ZEPHYR INFUSION CATHETER
K921247 · Target Therapeutics · Jun 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