Cleared Traditional

K974247 - 40 CC GRANDE

K974247 is the FDA 510(k) clearance for 40 CC GRANDE by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974247 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
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Feb 1998
Decision
90d
Days
Class 2
Risk

K974247 is an FDA 510(k) clearance for the 40 CC GRANDE. 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 February 10, 1998 after a review of 90 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 K974247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date February 10, 1998
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K974247.
DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES
K980780 · Datascope Corp. · May 1998
DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES
K980385 · Datascope Corp. · May 1998
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
K973962 · C.R. Bard, Inc. · Feb 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209 · Arrow Intl., Inc. · Jan 1998
8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMBER IAB-04830S
K963865 · Arrow Intl., Inc. · Sep 1997
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113 · Boston Scientific Corp · Sep 1997