Cleared Traditional

K911333 - RIGHT ATRIAL CATHETERS

K911333 is the FDA 510(k) clearance for RIGHT ATRIAL CATHETERS by Akcess Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K911333 · Akcess Medical Products, Inc. · Cardiovascular device
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Sep 1991
Decision
181d
Days
Class 2
Risk

K911333 is an FDA 510(k) clearance for the RIGHT ATRIAL CATHETERS. 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 September 23, 1991 after a review of 181 days - an extended review cycle.

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 K911333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1991
Decision Date September 23, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 125d · This submission: 181d
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 K911333.
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