Cleared Traditional

B-D ANGIOGRAPHIC CONTROL SYRINGE (K895318) - FDA 510(k) Clearance

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

K895318 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
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Jan 1990
Decision
143d
Days
Class 2
Risk

K895318 is an FDA 510(k) clearance for the B-D ANGIOGRAPHIC CONTROL SYRINGE. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 143 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K895318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1989
Decision Date January 19, 1990
Days to Decision 143 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 125d · This submission: 143d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 48
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K895318.
CONTRAST INJECTION LINES
K960674 · B.Braun Medical, Inc. · Sep 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381 · B.Braun Medical, Inc. · Feb 1996
BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP
K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1991
USCI PRESTO DISPOSABLE INFLATION DEVICE
K896415 · C.R. Bard, Inc. · Jan 1990
MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM)
K884913 · Merit Medical Systems, Inc. · Apr 1989
DISPOSABLE CORONARY CONTROL SYRINGE 12CC
K875196 · Merit Medical Systems, Inc. · Feb 1988