Cleared Traditional

K903158 - SITERITE NEEDLE GUIDE

K903158 is an FDA 510(k) clearance for SITERITE NEEDLE GUIDE, manufactured by Dymax Corp. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K903158 · Dymax Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1990
Decision
71d
Days
Class 2
Risk

K903158 is an FDA 510(k) clearance for the SITERITE NEEDLE GUIDE. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Dymax Corp (Pittsburgh, US). The FDA issued a Cleared decision on September 27, 1990 after a review of 71 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 Dymax Corp devices

FDA 510(k) Submission Details - K903158

510(k) Number K903158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1990
Decision Date September 27, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 125d · This submission: 71d
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 688
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K903158.
MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER
K903330 · Mallinckrodt Medical · Oct 1990
THE GUIDER CORONARY GUIDING CATHETER
K903216 · Intec Medical, Inc. · Oct 1990
TAPERED TIP THE GUIDER CORONARY GUIDING CATHETER
K903217 · Intec Medical, Inc. · Oct 1990
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