Cleared Traditional

K030135 - SAFETY INTRODUCER NEEDLE

K030135 is an FDA 510(k) clearance for SAFETY INTRODUCER NEEDLE, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K030135 · B.Braun Medical, Inc. · Cardiovascular device
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Jul 2003
Decision
182d
Days
Class 2
Risk

K030135 is an FDA 510(k) clearance for the SAFETY INTRODUCER NEEDLE. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on July 15, 2003 after a review of 182 days - an extended review cycle.

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

FDA 510(k) Submission Details - K030135

510(k) Number K030135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2003
Decision Date July 15, 2003
Days to Decision 182 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
57d slower than avg
Panel avg: 125d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

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 598
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K030135.
SELDINGER SAFETY NEEDLE INTRODUCER
K032404 · Hdc Corp. · Sep 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · W.L. Gore & Associates, Inc. · Aug 2003
APEEL CS CATHETER DELIVERY SYSTEM
K031906 · St Jude Medical · Jul 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K030944 · Edwards Lifesciences, LLC · Jun 2003
EDWARDS INTRODUCER SHEATH
K031087 · Edwards Lifesciences, LLC · Apr 2003
MEDAMICUS FLOWGUARD PEELABLE INTRODUCER
K030905 · Medamicus, Inc. · Apr 2003