Cleared Traditional

K860638 - NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON

K860638 is an FDA 510(k) clearance for NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON, 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 223-day FDA review.

K860638 · Kontron Instruments, Inc. · Cardiovascular device
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Oct 1986
Decision
223d
Days
Class 2
Risk

K860638 is an FDA 510(k) clearance for the NOVEMPERC 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 October 1, 1986 after a review of 223 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 - K860638

510(k) Number K860638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1986
Decision Date October 01, 1986
Days to Decision 223 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
98d slower than avg
Panel avg: 125d · This submission: 223d
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 K860638.
INTRA-AORTIC BALLOON PUMP MODEL KAAT
K875036 · Kontron Instruments, Inc. · May 1988
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000
K874816 · Kontron Instruments, Inc. · Apr 1988
SYSTEM 90 TRANSPORT
K863219 · Datascope Corp. · Jan 1987
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT
K860427 · Kontron Instruments, Inc. · May 1986
INTRA-AORTIC BALLOON PUMP MODEL K2000
K853062 · Kontron Instruments, Inc. · Jan 1986
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · Datascope Corp. · Aug 1985