Cleared Traditional

K943919 - 9.5 FR SENSATION DL INTRA-AORTIC BALLON...

K943919 is the FDA 510(k) clearance for 9.5 FR SENSATION DL INTRA-AORTIC BALLON... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K943919 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
223d
Days
Class 2
Risk

K943919 is an FDA 510(k) clearance for the 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on March 23, 1995 after a review of 223 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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

Submission Details

510(k) Number K943919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1994
Decision Date March 23, 1995
Days to Decision 223 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
98d slower than avg
Panel avg: 125d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K943919.
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221 · Boston Scientific Corp · Aug 1995
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
K945230 · Arrow Intl., Inc. · May 1995
BSC/CA MODEL 940 IAB
K940298 · Boston Scientific Corp · Apr 1995
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
K942454 · Datascope Corp. · Feb 1995
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
K944460 · Datascope Corp. · Dec 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · Boston Scientific Corp · Oct 1994