Cleared Traditional

K932268 - MODIFICATIONS TO INTRA-AORTIC BALLOONS

K932268 is an FDA 510(k) clearance for MODIFICATIONS TO INTRA-AORTIC BALLOONS, 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 259-day FDA review.

K932268 · Kontron Instruments, Inc. · Cardiovascular device
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Dec 1993
Decision
259d
Days
Class 2
Risk

K932268 is an FDA 510(k) clearance for the MODIFICATIONS TO INTRA-AORTIC BALLOONS. 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 December 15, 1993 after a review of 259 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 - K932268

510(k) Number K932268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1993
Decision Date December 15, 1993
Days to Decision 259 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
134d slower than avg
Panel avg: 125d · This submission: 259d
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 K932268.
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · Boston Scientific Corp · Oct 1994
INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION
K940231 · Datascope Corp. · Sep 1994
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
K940178 · Datascope Corp. · Aug 1994
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
K925248 · Kontron Instruments, Inc. · Sep 1993
9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER
K926000 · Boston Scientific Corp · Aug 1993
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
K911000 · Datascope Corp. · Aug 1993