Cleared Traditional

K930057 - ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET

K930057 is an FDA 510(k) clearance for ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUC..., 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 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

FDA 510(k) Submission Details - K930057

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.

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 K930057.
INTROPEEL V
K931218 · Menlo Care, Inc. · Sep 1993
LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES
K931662 · Pace Medical · Aug 1993
CORDIS CATHETER SHEATH INTRODUCER
K932733 · Cordis Corp. · Aug 1993
BALT INTRODUCER
K925633 · Target Therapeutics · Jun 1993
NEW LEAD INTRODUCER KITS, VARIOUS MODELS
K926340 · Telectronics Pacing Systems, Inc. · May 1993
CORDIS NIHON CATHETER SHEATH INTRODUCER
K931102 · Cordis Corp. · May 1993