Cleared Traditional

K952884 - NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

K952884 is an FDA 510(k) clearance for NOPROFILE OLBERT CATHETER SYSTEM BALLOO..., 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 243-day FDA review.

K952884 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
243d
Days
Class 2
Risk

K952884 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION 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 February 21, 1996 after a review of 243 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 - K952884

510(k) Number K952884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1995
Decision Date February 21, 1996
Days to Decision 243 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
118d slower than avg
Panel avg: 125d · This submission: 243d
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 K952884.
ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
K960501 · Boston Scientific Corp · Apr 1996
BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER
K960517 · C.R. Bard, Inc. · Apr 1996
MEGA PTA BALLOON CATHETER
K955886 · Cordis Corp. · Mar 1996
MS CLASSIQUE BALLOON DIATATION CATHETER
K953298 · Meadox Medicals, Div. Boston Scientific Corp. · Feb 1996
COURIER BALLOON DILATATION CATHETER
K953569 · Boston Scientific Corp · Dec 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
K953608 · Meadox Medicals, Div. Boston Scientific Corp. · Dec 1995