Cleared Traditional

K930057 - ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUC...

K930057 is the FDA 510(k) clearance for ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUC... by B.Braun Medical, Inc.. It is a Class 2 Cardiovascular device (product code DYB) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K930057 · B.Braun Medical, Inc. · Cardiovascular device
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Aug 1993
Decision
212d
Days
Class 2
Risk

K930057 is an FDA 510(k) clearance for the ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET. 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 August 6, 1993 after a review of 212 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

Submission Details

510(k) Number K930057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1993
Decision Date August 06, 1993
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
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 K930057.
CATHETER INTRODUCER MODIFICATION
K934285 · Daig Corp. · Nov 1993
BURRON CARDIOVASCULAR ANGESTAT(TM)
K931743 · B.Braun Medical, Inc. · Nov 1993
CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
BALT INTRODUCER
K925633 · Target Therapeutics · Jun 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993
ARROW FISCHELL KINK RESIST PERCUT SHEATH INTRO SET
K924607 · Arrow Intl., Inc. · Apr 1993