Cleared Traditional

K933033 - GUIDING CATHETER HEMOSTASIS VALVE CAP

K933033 is an FDA 510(k) clearance for GUIDING CATHETER HEMOSTASIS VALVE CAP, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 80-day FDA review.

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

FDA 510(k) Submission Details - K933033

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
Combination Product No
PCCP Authorized No
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.

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 600
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K933033.
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER
K934988 · Scimed Life Systems, Inc. · Jan 1994
ACS POWERGUIDE CORONARY GUIDING CATHETER
K934009 · Advanced Cardiovascular Systems, Inc. · Jan 1994
USCI SUPER 6 6F PTCA GUIDING CATHETER
K933019 · C.R. Bard, Inc. · Sep 1993
CORDIS 9 F GUIDING CATHETER
K925131 · Cordis Corp. · May 1993
ITC CATHETERS W/ HYDROMER
K922609 · Interventional Therapeutics Corp. · Apr 1993
ACS ET HI-FLOW/ENHANCED TORQUE CORONARY GUID CATH
K926421 · Advanced Cardiovascular Systems, Inc. · Mar 1993