Cleared Traditional

K920331 - RIGHT ATRIAL CATHETER KITS

K920331 is the FDA 510(k) clearance for RIGHT ATRIAL CATHETER KITS by Akcess Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920331 · Akcess Medical Products, Inc. · Cardiovascular device
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Apr 1992
Decision
90d
Days
Class 2
Risk

K920331 is an FDA 510(k) clearance for the RIGHT ATRIAL CATHETER KITS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Akcess Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Akcess Medical Products, Inc. devices

Submission Details

510(k) Number K920331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 23, 1992
Decision Date April 22, 1992
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K920331.
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K921311 · Cordis Corp. · Sep 1992
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K914984 · E-Z-Em, Inc. · May 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992
TRACKER(R) UNIBODY CATH & TRACKER 25 CATH,MODIFIED
K915521 · Target Therapeutics · Mar 1992
CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER
K915374 · Cordis Corp. · Feb 1992
CORDIS SHUTTLE CATHETER
K915777 · Cordis Corp. · Feb 1992