Cleared Traditional

K896597 - THE SIDEWINDER 40CC DL INTRA-AORTIC BAL...

K896597 is the FDA 510(k) clearance for THE SIDEWINDER 40CC DL INTRA-AORTIC BAL... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K896597 · Boston Scientific Corp · Cardiovascular device
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Feb 1990
Decision
83d
Days
Class 2
Risk

K896597 is an FDA 510(k) clearance for the THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.. 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 February 12, 1990 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K896597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date February 12, 1990
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 K896597.
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497 · Datascope Corp. · Aug 1990
SERIES 3001 IABP
K900281 · Boston Scientific Corp · Apr 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K896920 · Boston Scientific Corp · Mar 1990
PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI
K896430 · Datascope Corp. · Feb 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K894942 · Boston Scientific Corp · Sep 1989
10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892797 · Kontron Instruments, Inc. · Sep 1989