Cleared Traditional

K895972 - CURITY(R) PERCUTANEOUS CATHETERS

K895972 is an FDA 510(k) clearance for CURITY PERCUTANEOUS CATHETERS, manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K895972 · Kendall Healthcare Products Co. Div.Of Tyco Health · Cardiovascular device
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Mar 1990
Decision
152d
Days
Class 2
Risk

K895972 is an FDA 510(k) clearance for the CURITY(R) PERCUTANEOUS CATHETERS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on March 13, 1990 after a review of 152 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.

FDA 510(k) Submission Details - K895972

510(k) Number K895972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1989
Decision Date March 13, 1990
Days to Decision 152 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
27d slower than avg
Panel avg: 125d · This submission: 152d
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 861
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K895972.
MANAN ARTERIAL CATHETER NEEDLE
K900978 · Manan Medical Products, Inc. · Aug 1990
INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE
K900998 · Intec Medical, Inc. · Aug 1990
UNIVERSAL DELIVERY SYSTEM CATHETER
K900657 · Microvena Corp. · May 1990
SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
K897082 · Schneider Intl., Ltd. · Mar 1990
PSG(TM) EDM(TM) INFUSION CATHETER
K895932 · Peripheral Systems Group · Jan 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
K895972 · CURITY(R) PERCUTANEOUS CATHETERS
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