Cleared Traditional

K964642 - MEDRAD DISPOSABLE SYRINGES

K964642 is an FDA 510(k) clearance for MEDRAD DISPOSABLE SYRINGES, manufactured by Medrad, Inc.. The device is a Class 2 Cardiovascular device with product code DXT cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K964642 · Medrad, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
161d
Days
Class 2
Risk

K964642 is an FDA 510(k) clearance for the MEDRAD DISPOSABLE SYRINGES. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Medrad, Inc. (Indianola, US). The FDA issued a Cleared decision on April 29, 1997 after a review of 161 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 Medrad, Inc. devices

FDA 510(k) Submission Details - K964642

510(k) Number K964642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1996
Decision Date April 29, 1997
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
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 169
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K964642.
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · Merit Medical Systems, Inc. · Nov 1997
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · Coeur Laboratories, Inc. · Oct 1997
ANGIOMAT ILLUMENA
K963071 · Mallinckrodt Inc., Liebel-Flarsheim Business · Sep 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc. · Mar 1997
RNS STERILE, DISPOSABLE CT BIOPSY TRAY
K955685 · Contour Fabricators of Florida, Inc. · Oct 1996
CONTRAST INJECTION LINES
K960674 · B.Braun Medical, Inc. · Sep 1996