Cleared Traditional

K962141 - VOLUME CONTROL SYRINGE MODEL VCD-SYR-10

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

K962141 · B.Braun Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K962141

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.

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 163
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K962141.
COEUR 130 ML ANGIOGRAPHIC SYRINGE
K971712 · Coeur Laboratories, Inc. · Oct 1997
ANGIOMAT ILLUMENA
K963071 · Mallinckrodt Inc., Liebel-Flarsheim Business · Sep 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 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
FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211
K960965 · Coeur Laboratories, Inc. · Sep 1996