Cleared Traditional

K962141 - VOLUME CONTROL SYRINGE MODEL VCD-SYR-10

K962141 is the FDA 510(k) clearance for VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 by B.Braun Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K962141 · B.Braun Medical, Inc. · Cardiovascular device
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Mar 1997
Decision
289d
Days
Class 2
Risk

K962141 is an FDA 510(k) clearance for the VOLUME CONTROL SYRINGE MODEL VCD-SYR-10. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 289 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 B.Braun Medical, Inc. devices

Submission Details

510(k) Number K962141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1996
Decision Date March 19, 1997
Days to Decision 289 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
164d slower than avg
Panel avg: 125d · This submission: 289d
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 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K962141.
MEDRAD VISTRON CT INJECTOR SYSTEM
K982814 · Medrad, Inc. · Oct 1998
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · Merit Medical Systems, Inc. · Nov 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 1997
CONTRAST INJECTION LINES
K960674 · B.Braun Medical, Inc. · Sep 1996
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381 · B.Braun Medical, Inc. · Feb 1996
MEDRAD SPECTRIS MR INJECTOR
K935668 · Medrad, Inc. · Sep 1995