Cleared Traditional

MEADOX SURGIMED BALLOON CATHETER (K923947) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K923947 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
421d
Days
Class 2
Risk

K923947 is an FDA 510(k) clearance for the MEADOX SURGIMED BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on September 30, 1993 after a review of 421 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 Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K923947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date September 30, 1993
Days to Decision 421 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 125d · This submission: 421d
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 154
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K923947.
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · Boston Scientific Corp · Dec 1993
ULTRA THIN BALLOON DILATATION CATHETER
K924320 · Boston Scientific Corp · Nov 1993
ULTRA THIN BALLOON DILATATION CATHETER
K923611 · Boston Scientific Corp · Nov 1993
ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED
K924358 · Cook, Inc. · May 1993
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · Boston Scientific Corp · Dec 1992
BALLOON DILATATION CATHETER
K922610 · Boston Scientific Corp · Nov 1992