Cleared Traditional

K954431 - PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS

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

K954431 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K954431

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.

DSP Device Classification - Class 2, Special Controls

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 145
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
TRANSPORT CART
K952576 · Belmont Instrument Corp. · Dec 1995
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221 · Boston Scientific Corp · Aug 1995
EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)
K950687 · Belmont Instrument Corp. · May 1995