Cleared Traditional

NOPROFILE OLBERT CATHETER SYSTEM (K944989) - FDA 510(k) Clearance

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

K944989 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 1995
Decision
196d
Days
Class 2
Risk

K944989 is an FDA 510(k) clearance for the NOPROFILE OLBERT CATHETER SYSTEM. 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 April 26, 1995 after a review of 196 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

Submission Details

510(k) Number K944989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1994
Decision Date April 26, 1995
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
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
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