Cleared Traditional

K897082 - SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR

K897082 is an FDA 510(k) clearance for SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR, manufactured by Schneider Intl., Ltd.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K897082 · Schneider Intl., Ltd. · Cardiovascular device
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Mar 1990
Decision
76d
Days
Class 2
Risk

K897082 is an FDA 510(k) clearance for the SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Schneider Intl., Ltd. (Minneapolis, US). The FDA issued a Cleared decision on March 6, 1990 after a review of 76 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 Schneider Intl., Ltd. devices

FDA 510(k) Submission Details - K897082

510(k) Number K897082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date March 06, 1990
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
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 601
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K897082.
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
MANAN ARTERIAL CATHETER NEEDLE
K900978 · Manan Medical Products, Inc. · Aug 1990
CURITY(R) PERCUTANEOUS CATHETERS
K895972 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · Target Therapeutics · Sep 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989