Cleared Traditional

K932218 - CARDIAC CATH OR ANGIOGRAPHIC TRAYS

K932218 is an FDA 510(k) clearance for CARDIAC CATH OR ANGIOGRAPHIC TRAYS, manufactured by Associated Medical Products Co.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K932218 · Associated Medical Products Co. · Cardiovascular device
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Aug 1993
Decision
112d
Days
Class 2
Risk

K932218 is an FDA 510(k) clearance for the CARDIAC CATH OR ANGIOGRAPHIC TRAYS. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Associated Medical Products Co. (St. Louis Park, US). The FDA issued a Cleared decision on August 27, 1993 after a review of 112 days - within the typical 510(k) review window.

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: 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 Associated Medical Products Co. devices

FDA 510(k) Submission Details - K932218

510(k) Number K932218 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 07, 1993
Decision Date August 27, 1993
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 413
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K932218.
CARAPACE ANGIOGRAPHY TRAYS
K931629 · Carapace, Inc. · Dec 1993
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993
SOFTOUCH DIAGNOSTIC INTRAVASCULAR CATHETER
K931479 · Mallinckrodt Medical · Oct 1993
SCIMED 6 FR., 7 FR., AND 8 FR.,TRIGUIDE GUIDING
K932420 · Scimed Life Systems, Inc. · Aug 1993
ANGIOGRAPHIC CATHETER
K926243 · Target Therapeutics · Aug 1993
SCIMED 6F ANGIOGRAPHIC CATHETER
K932542 · Scimed Life Systems, Inc. · Aug 1993