Cleared Traditional

K942635 - MEADOX SURGIMED NOPROFILE OLBERT CATHET...

K942635 is the FDA 510(k) clearance for MEADOX SURGIMED NOPROFILE OLBERT CATHET... by Meadox Medicals, Div. Boston Scientific Corp.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K942635 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
151d
Days
Class 2
Risk

K942635 is an FDA 510(k) clearance for the MEADOX SURGIMED 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 November 1, 1994 after a review of 151 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 K942635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1994
Decision Date November 01, 1994
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
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 247
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K942635.
SCIMED VIPER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K944815 · Scimed Life Systems, Inc. · Nov 1994
BARD PERIPHERAL BALLOON DILATATION CATHETER
K942400 · C.R. Bard, Inc. · Nov 1994
CORDIS SAVVY PTA BALLOON CATHETER
K942094 · Cordis Corp. · Nov 1994
MS CLASSIQUE BALLOON CATHETER
K942293 · Meadox Medicals, Div. Boston Scientific Corp. · 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