Cleared Traditional

K931560 - CARDIAC CATHETERIZATION TRAY

K931560 is the FDA 510(k) clearance for CARDIAC CATHETERIZATION TRAY by Clinipad Corp.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 468-day FDA review.

K931560 · Clinipad Corp. · Cardiovascular device
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Jul 1994
Decision
468d
Days
Class 2
Risk

K931560 is an FDA 510(k) clearance for the CARDIAC CATHETERIZATION TRAY. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Clinipad Corp. (Guilford, US). The FDA issued a Cleared decision on July 11, 1994 after a review of 468 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Clinipad Corp. devices

Submission Details

510(k) Number K931560 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 30, 1993
Decision Date July 11, 1994
Days to Decision 468 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
343d slower than avg
Panel avg: 125d · This submission: 468d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 234
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K931560.
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HAND CONTROLLED SYRINGE
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DYE MANAGEMENT SYSTEM
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TRANSIT INFUSION CATHETER
K936260 · Cordis Corp. · May 1994