Cleared Traditional

BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP (K910873) - FDA 510(k) Clearance

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

K910873 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Cardiovascular device
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May 1991
Decision
89d
Days
Class 2
Risk

K910873 is an FDA 510(k) clearance for the BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP. 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 May 29, 1991 after a review of 89 days - a notably fast clearance 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: 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K910873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date May 29, 1991
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 K910873.
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc. · Mar 1997
CONTRAST INJECTION LINES
K960674 · B.Braun Medical, Inc. · Sep 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381 · B.Braun Medical, Inc. · Feb 1996
B-D ANGIOGRAPHIC CONTROL SYRINGE
K895318 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
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