Cleared Traditional

K831729 - PERCUTANEOUS CATHETER INSERTION TRAY

K831729 is an FDA 510(k) clearance for PERCUTANEOUS CATHETER INSERTION TRAY, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K831729 · American Pharmaseal Div. Ahsc · Cardiovascular device
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Jul 1983
Decision
48d
Days
Class 2
Risk

K831729 is an FDA 510(k) clearance for the PERCUTANEOUS CATHETER INSERTION TRAY. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K831729

510(k) Number K831729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1983
Decision Date July 18, 1983
Days to Decision 48 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
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 619
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K831729.
DUOFLO 6F
K833303 · Argon Medical Corp. · Dec 1983
ULTRA LIGHT RAAF CATHETER
K832784 · Quinton, Inc. · Oct 1983
AMPLATZ HEPARIN COATED CATHETER
K832178 · Cook, Inc. · Aug 1983
CATHETER INSERTION TRAYS, VARIOUS #'S
K831807 · American Pharmaseal Div. Ahsc · Jul 1983
CORONARY GUIDING CATHETER-MODIFIED
K831563 · Advanced Cardiovascular Systems, Inc. · Jun 1983
CORONARY INFUSION CATHETER
K831717 · Advanced Cardiovascular Systems, Inc. · Jun 1983