Cleared Traditional

K951602 - PULSE*SPRAY INFUSION SYSTEM (FDA 510(k) Clearance)

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

K951602 · Angiodynamics, Div. E-Z-Em, Inc. · Cardiovascular device
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Jun 1995
Decision
92d
Days
Class 2
Risk

K951602 is an FDA 510(k) clearance for the PULSE*SPRAY INFUSION SYSTEM. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Angiodynamics, Div. E-Z-Em, Inc. (Queensbury, US). The FDA issued a Cleared decision on June 14, 1995 after a review of 92 days - within the typical 510(k) review window.

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. 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 Angiodynamics, Div. E-Z-Em, Inc. devices

Submission Details

510(k) Number K951602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1995
Decision Date June 14, 1995
Days to Decision 92 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
33d faster than avg
Panel avg: 125d · This submission: 92d
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 172
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