Cleared Traditional

K900657 - UNIVERSAL DELIVERY SYSTEM CATHETER

K900657 is an FDA 510(k) clearance for UNIVERSAL DELIVERY SYSTEM CATHETER, manufactured by Microvena Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K900657 · Microvena Corp. · Cardiovascular device
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May 1990
Decision
89d
Days
Class 2
Risk

K900657 is an FDA 510(k) clearance for the UNIVERSAL DELIVERY SYSTEM CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Microvena Corp. (Findley, US). The FDA issued a Cleared decision on May 9, 1990 after a review of 89 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 Microvena Corp. devices

FDA 510(k) Submission Details - K900657

510(k) Number K900657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1990
Decision Date May 09, 1990
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 663
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K900657.
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
MANAN ARTERIAL CATHETER NEEDLE
K900978 · Manan Medical Products, Inc. · Aug 1990
INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE
K900998 · Intec Medical, Inc. · Aug 1990
CURITY(R) PERCUTANEOUS CATHETERS
K895972 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1990
SCHNEIDER SIDEKICK MONORAIL Y-CONNECTOR
K897082 · Schneider Intl., Ltd. · Mar 1990
PSG(TM) EDM(TM) INFUSION CATHETER
K895932 · Peripheral Systems Group · Jan 1990