Cleared Traditional

K892797 - 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTI...

K892797 is an FDA 510(k) clearance for 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTI..., manufactured by Kontron Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K892797 · Kontron Instruments, Inc. · Cardiovascular device
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Sep 1989
Decision
156d
Days
Class 2
Risk

K892797 is an FDA 510(k) clearance for the 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Everett, US). The FDA issued a Cleared decision on September 20, 1989 after a review of 156 days - an extended review 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: 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 Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K892797

510(k) Number K892797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date September 20, 1989
Days to Decision 156 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
31d slower than avg
Panel avg: 125d · This submission: 156d
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 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K892797.
THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.
K896597 · Boston Scientific Corp · Feb 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
9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892798 · Kontron Instruments, Inc. · Sep 1989
8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON
K892799 · Kontron Instruments, Inc. · Sep 1989
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000
K892878 · Kontron Instruments, Inc. · Sep 1989