Cleared Traditional

GUIDING CATHETER HEMOSTASIS VALVE CAP (K933033) - FDA 510(k) Clearance

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

K933033 · Arrow Intl., Inc. · Cardiovascular device
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Sep 1993
Decision
80d
Days
Class 2
Risk

K933033 is an FDA 510(k) clearance for the GUIDING CATHETER HEMOSTASIS VALVE CAP. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on September 10, 1993 after a review of 80 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 Arrow Intl., Inc. devices

Submission Details

510(k) Number K933033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1993
Decision Date September 10, 1993
Days to Decision 80 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 125d · This submission: 80d
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 317
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K933033.
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CORDIS 9 F GUIDING CATHETER
K925131 · Cordis Corp. · May 1993
CORDIS SHUTTLE CATHETER W/ SIDEHOLES
K921311 · Cordis Corp. · Sep 1992
VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM)
K914856 · Cook, Inc. · May 1992