Cleared Traditional

K930745 - BURRON EXPEDITER BRAIDED BALLOON PTA CA...

K930745 is the FDA 510(k) clearance for BURRON EXPEDITER BRAIDED BALLOON PTA CA... by B.Braun Medical, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 461-day FDA review.

K930745 · B.Braun Medical, Inc. · Cardiovascular device
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May 1994
Decision
461d
Days
Class 2
Risk

K930745 is an FDA 510(k) clearance for the BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 19, 1994 after a review of 461 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K930745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1993
Decision Date May 19, 1994
Days to Decision 461 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
336d slower than avg
Panel avg: 125d · This submission: 461d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K930745.
MS CLASSIQUE BALLOON CATHETER
K943298 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1994
SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS
K942154 · Boston Scientific Scimed, Inc. · Aug 1994
CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION
K940868 · Cordis Corp. · Jul 1994
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K934378 · Scimed Life Systems, Inc. · Jan 1994
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
K934411 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1994
CORDIS OPTA 5(TM), MODIFICATION
K933236 · Cordis Corp. · Dec 1993