Cleared Traditional

K955820 - BRAUN HEMOSTASIS INTRODUCERS

K955820 is the FDA 510(k) clearance for BRAUN HEMOSTASIS INTRODUCERS by B.Braun Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955820 · B.Braun Medical, Inc. · Cardiovascular device
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Mar 1996
Decision
90d
Days
Class 2
Risk

K955820 is an FDA 510(k) clearance for the BRAUN HEMOSTASIS INTRODUCERS. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 25, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 K955820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1995
Decision Date March 25, 1996
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 391
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K955820.
INPUT TUOHY-BORST LOCKING DEVICE
K960445 · C.R. Bard, Inc. · Aug 1996
INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F)
K961135 · C.R. Bard, Inc. · Apr 1996
BRAUN HEMOSTASIS INTRODUCERS
K960406 · B.Braun Medical, Inc. · Apr 1996
TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
K955785 · C.R. Bard, Inc. · Mar 1996
CORDIS BRITE TIP SHEATH INTRODUCER
K954595 · Cordis Corp. · Dec 1995
DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS
K954317 · Daig Corp. · Nov 1995