Cleared Traditional

K973334 - OZ POWER SYRINGE

K973334 is an FDA 510(k) clearance for OZ POWER SYRINGE, manufactured by Cardiovascular Innovations. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K973334 · Cardiovascular Innovations · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
211d
Days
Class 2
Risk

K973334 is an FDA 510(k) clearance for the OZ POWER SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Cardiovascular Innovations (Dallas, US). The FDA issued a Cleared decision on April 3, 1998 after a review of 211 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Innovations devices

FDA 510(k) Submission Details - K973334

510(k) Number K973334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1997
Decision Date April 03, 1998
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXT Device Classification - Class 2, Special Controls

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - DXT Injector And Syringe, Angiographic

All 128
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K973334.
MEDRAD VISTRON CT INJECTOR SYSTEM
K991557 · Medrad, Inc. · Jul 1999
UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET
K984418 · Medrad, Inc. · Mar 1999
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814 · Medrad, Inc. · Oct 1998
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · Merit Medical Systems, Inc. · Nov 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · Coeur Laboratories, Inc. · Oct 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 1997