Cleared Traditional

K971673 - 40 CC SUMO

K971673 is an FDA 510(k) clearance for 40 CC SUMO, 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 90-day FDA review.

K971673 · Boston Scientific Corp · Cardiovascular device
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Aug 1997
Decision
90d
Days
Class 2
Risk

K971673 is an FDA 510(k) clearance for the 40 CC SUMO. 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 August 5, 1997 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

FDA 510(k) Submission Details - K971673

510(k) Number K971673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1997
Decision Date August 05, 1997
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.

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 K971673.
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
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K965236 · Datascope Corp. · Jul 1997
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
K963920 · Arrow Intl., Inc. · Jun 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
K964987 · Datascope Corp. · Mar 1997