Cleared Traditional

SITERITE NEEDLE GUIDE (K903158) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903158 · Dymax Corp · Cardiovascular device
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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

Submission Details

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.

Device Classification

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 304
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K903158.
CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER
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NEW USCI 7F PTCA GUIDING CATHETER
K905249 · C.R. Bard, Inc. · Feb 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
COOK CORONARY GUIDING CATHETER
K902905 · Cook, Inc. · Sep 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989