Cleared Traditional

K902057 - PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG

K902057 is an FDA 510(k) clearance for PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LAB..., 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 141-day FDA review.

K902057 · Datascope Corp. · Cardiovascular device
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Sep 1990
Decision
141d
Days
Class 2
Risk

K902057 is an FDA 510(k) clearance for the PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG. 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 September 25, 1990 after a review of 141 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

FDA 510(k) Submission Details - K902057

510(k) Number K902057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1990
Decision Date September 25, 1990
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
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 K902057.
DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL
K903893 · Datascope Corp. · Oct 1990
DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL
K904018 · Datascope Corp. · Oct 1990
DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL
K903736 · Datascope Corp. · Oct 1990
9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON
K892222 · Kontron Instruments, Inc. · Sep 1990
PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON
K896497 · Datascope Corp. · Aug 1990
SERIES 3001 IABP
K900281 · Boston Scientific Corp · Apr 1990