# K973334: OZ Power Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Innovations
- Decided: Apr 3, 1998 after 211 days
- Product code: DXT (Injector And Syringe, Angiographic)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822536 (1982). 2 ancestors in all.
19 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822536: MARK V, Medrad, Inc. (1982). Our OCR of the scanned summary read K822538, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “MedRad Mark V Angiographic Injector”.
- K852640: Monoject Sterile 35CC Syringes, Sherwood Medical Co. (1985) Summary page 1.

## Most influential descendants
- K051799: Disposable CT/MR Syringes for Nemoto Injectors (2005), 18 descendants of its own
- K072696: Ant Angiographic Syringes, Model (S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 (2008), 15 descendants of its own
- K151960: Sterile High-pressure Angiographic Syringes for Single-use (2016), 8 descendants of its own
- K192657: Sterile High-pressure Angiographic Syringes for Single-use (2020), 4 descendants of its own
- K211564: Sterile High-pressure Angiographic Syringes for Single-use (2021), 2 descendants of its own

## Recalls of this device
- Apr 6, 2021 · Class II · Z-1529-2021: The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.
- Jul 18, 2007 · Not classified · Z-0008-2008: Sterility of device may be compromised due to breach in sterile barrier.

## Indications for use
injection of contrast media into the heart, great vessels, and coronary arteries, to study the heart and vessels by x-ray photography

Source page: https://510kreport.com/device/K973334
Methodology: https://510kreport.com/methodology