Cleared Traditional

K896497 - PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON

K896497 is an FDA 510(k) clearance for PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K896497 · Datascope Corp. · Cardiovascular device
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Aug 1990
Decision
276d
Days
Class 2
Risk

K896497 is an FDA 510(k) clearance for the PERCOR STAT-DL 8.5 FR 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 17, 1990 after a review of 276 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

FDA 510(k) Submission Details - K896497

510(k) Number K896497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1989
Decision Date August 17, 1990
Days to Decision 276 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
151d slower than avg
Panel avg: 125d · This submission: 276d
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 145
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K896497.
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
K903736 · Datascope Corp. · Oct 1990
PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG
K902057 · Datascope Corp. · Sep 1990
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
K892222 · Kontron Instruments, Inc. · Sep 1990
SERIES 3001 IABP
K900281 · Boston Scientific Corp · Apr 1990
ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS
K895433 · Aries Medical, Inc. · Apr 1990
SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER
K896920 · Boston Scientific Corp · Mar 1990