Cleared Traditional

K942293 - MS CLASSIQUE BALLOON CATHETER

K942293 is an FDA 510(k) clearance for MS CLASSIQUE BALLOON CATHETER, manufactured by Meadox Medicals, Div. Boston Scientific Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K942293 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
160d
Days
Class 2
Risk

K942293 is an FDA 510(k) clearance for the MS CLASSIQUE 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 October 18, 1994 after a review of 160 days - an extended review cycle.

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: 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 Meadox Medicals, Div. Boston Scientific Corp. devices

FDA 510(k) Submission Details - K942293

510(k) Number K942293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1994
Decision Date October 18, 1994
Days to Decision 160 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
35d slower than avg
Panel avg: 125d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

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 358
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K942293.
CORDIS SAVVY PTA BALLOON CATHETER
K942094 · Cordis Corp. · Nov 1994
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM
K942635 · Meadox Medicals, Div. Boston Scientific Corp. · Nov 1994
OPTI-PLAST ANGIOPLASTY CATHETER
K941706 · Vas-Cath, Inc. · Oct 1994
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