Cleared Traditional

PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON (K911000) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911000 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
901d
Days
Class 2
Risk

K911000 is an FDA 510(k) clearance for the PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON. 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 25, 1993 after a review of 901 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Datascope Corp. devices

Submission Details

510(k) Number K911000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date August 25, 1993
Days to Decision 901 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
776d slower than avg
Panel avg: 125d · This submission: 901d
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 161
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K911000.
AC3™ Range™ Intra-Aortic Balloon Pump
K250542 · Arrow International, LLC · Mar 2025
AC3™ Series IABP
K232343 · Arrow International, LLC · Aug 2023
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP
K201112 · Arrow International, Inc. · May 2020
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit
K200634 · Arrow International, Inc. · Apr 2020
AC3 Series Intra-Aortic Balloon Pump (IABP)
K192238 · Arrow International, Teleflex · Nov 2019
UltraFlex IAB
K190101 · Arrow International, Inc. · Jun 2019