Cleared Traditional

K954431 - PERCUTANEOUS INTRA-AORTIC BALLOON CATHE...

K954431 is the FDA 510(k) clearance for PERCUTANEOUS INTRA-AORTIC BALLOON CATHE... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K954431 · Boston Scientific Corp · Cardiovascular device
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Jan 1996
Decision
108d
Days
Class 2
Risk

K954431 is an FDA 510(k) clearance for the PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on January 11, 1996 after a review of 108 days - within the typical 510(k) review window.

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 K954431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date January 11, 1996
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 K954431.
ARROW SHEATHLESS INTRA-AORTIC BALLOON CATHETER
K961358 · Arrow Intl., Inc. · Jul 1996
8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH)
K960713 · Arrow Intl., Inc. · May 1996
PERCOR STAT-DL 9.5 FR. 34 & 40CC
K960166 · Datascope Corp. · Apr 1996
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