Cleared Traditional

K942154 - SCHNEIDER TOTAL CROSS AND MATCH 35 PERC...

K942154 is the FDA 510(k) clearance for SCHNEIDER TOTAL CROSS AND MATCH 35 PERC... by Boston Scientific Scimed, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K942154 · Boston Scientific Scimed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
125d
Days
Class 2
Risk

K942154 is an FDA 510(k) clearance for the SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CAT.... Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 125 days - within the typical 510(k) review window.

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 Boston Scientific Scimed, Inc. devices

Submission Details

510(k) Number K942154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1994
Decision Date August 18, 1994
Days to Decision 125 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
At panel average
Panel avg: 125d · This submission: 125d
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 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K942154.
MEADOX SURGIMED NOPROFILE OLBERT CATHETER SYSTEM
K942635 · Meadox Medicals, Div. Boston Scientific 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
CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION
K940868 · Cordis Corp. · Jul 1994
BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER
K930745 · B.Braun Medical, Inc. · May 1994
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K934378 · Scimed Life Systems, Inc. · Jan 1994