Cleared Traditional

K902057 - PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LAB...

K902057 is the FDA 510(k) clearance for PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LAB... by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K902057 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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