Cleared Traditional

K903344 - 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI...

K903344 is an FDA 510(k) clearance for 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI..., 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 174-day FDA review.

K903344 · Kontron Instruments, Inc. · Cardiovascular device
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Jan 1991
Decision
174d
Days
Class 2
Risk

K903344 is an FDA 510(k) clearance for the 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM). 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 January 15, 1991 after a review of 174 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 - K903344

510(k) Number K903344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date January 15, 1991
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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 K903344.
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K910997 · Datascope Corp. · Nov 1991
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
K905313 · Kontron Instruments, Inc. · Jun 1991
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
K905056 · Datascope Corp. · Jun 1991
DATASCOPE PERCOR STAT DL 10.5 FR 50CC
K903930 · Datascope Corp. · Nov 1990
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
K904414 · Datascope Corp. · Oct 1990
PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON
K903769 · Datascope Corp. · Oct 1990