Cleared Traditional

K895542 - SONICATH(TM) 5 F

K895542 is an FDA 510(k) clearance for SONICATH(TM) 5 F, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K895542 · Boston Scientific Corp · Cardiovascular device
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Apr 1990
Decision
205d
Days
Class 2
Risk

K895542 is an FDA 510(k) clearance for the SONICATH(TM) 5 F. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on April 6, 1990 after a review of 205 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Corp devices

FDA 510(k) Submission Details - K895542

510(k) Number K895542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1989
Decision Date April 06, 1990
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 403
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K895542.
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
K901691 · Cardiovascular Imaging Systems, Inc. · Jul 1990
SCIMED CORONARY GUIDING CATHETER
K895437 · Scimed Life Systems, Inc. · Jun 1990
USCI 7F LARGE LUMEN GUIDING CATHETER
K895180 · C.R. Bard, Inc. · Apr 1990
CORDIS SHUTTLE CATHETER
K896308 · Cordis Corp. · Mar 1990
SCHNEIDER MONORAIL-PMC PRESSURE MONITORING CATH.
K896741 · Schneider Intl., Ltd. · Feb 1990
GUIDING CATHETER
K895146 · Peripheral Systems Group · Jan 1990