Cleared Traditional

K895972 - CURITY 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.

View all Kendall Healthcare Products Co. Div.Of Tyco Health devices

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 650
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K895972.
MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER
K903330 · Mallinckrodt Medical · Oct 1990
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
MANAN ARTERIAL CATHETER NEEDLE
K900978 · Manan Medical Products, Inc. · Aug 1990
SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
K897082 · Schneider Intl., Ltd. · Mar 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · Target Therapeutics · Sep 1989