Cleared Traditional

K911000 - PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC...

K911000 is the FDA 510(k) clearance for PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 901-day FDA review.

K911000 · Datascope Corp. · Cardiovascular device
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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
Combination Product No
PCCP Authorized No
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 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K911000.
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268 · Kontron Instruments, Inc. · Dec 1993
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
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
K914802 · Datascope Corp. · Aug 1993
PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON
K920427 · Datascope Corp. · Aug 1993
PEDIATRIC INTRA-AORTIC BALLOON CATHETERS
K905663 · Datascope Corp. · Aug 1993