Cleared Traditional

K850482 - DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AO...

K850482 is the FDA 510(k) clearance for DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AO... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K850482 · Datascope Corp. · Cardiovascular device
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Aug 1985
Decision
196d
Days
Class 2
Risk

K850482 is an FDA 510(k) clearance for the DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Oakland, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 196 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 Datascope Corp. devices

Submission Details

510(k) Number K850482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1985
Decision Date August 22, 1985
Days to Decision 196 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
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K850482.
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON
K860638 · Kontron Instruments, Inc. · Oct 1986
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
IABP #90 SYSTEM
K831235 · Datascope Corp. · Feb 1985
PERCOR 9.5 FR IAB ON DATASCOPE CO2
K833828 · Datascope Corp. · Feb 1985
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307 · Datascope Corp. · Nov 1983