Cleared Traditional

K880289 - DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-...

K880289 is the FDA 510(k) clearance for DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K880289 · Datascope Corp. · Cardiovascular device
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Jun 1988
Decision
137d
Days
Class 2
Risk

K880289 is an FDA 510(k) clearance for the DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL. 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 June 10, 1988 after a review of 137 days - within the typical 510(k) review window.

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 K880289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date June 10, 1988
Days to Decision 137 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
12d slower than avg
Panel avg: 125d · This submission: 137d
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 K880289.
INTRA AORTIC BALLOON
K893243 · Datascope Corp. · Jun 1989
10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC
K882274 · Kontron Instruments, Inc. · Mar 1989
9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON
K882508 · Kontron Instruments, Inc. · Mar 1989
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