Cleared Traditional

K913847 - SYSTEM 90 AND SYSTEM 90T

K913847 is the FDA 510(k) clearance for SYSTEM 90 AND SYSTEM 90T by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K913847 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
197d
Days
Class 2
Risk

K913847 is an FDA 510(k) clearance for the SYSTEM 90 AND SYSTEM 90T. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Montvale, US). The FDA issued a Cleared decision on March 11, 1992 after a review of 197 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

Submission Details

510(k) Number K913847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1991
Decision Date March 11, 1992
Days to Decision 197 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d slower than avg
Panel avg: 125d · This submission: 197d
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 K913847.
BARD(R) INTRA AORTIC BALLOON
K924382 · C.R. Bard, Inc. · Apr 1993
SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE
K921638 · Datascope Corp. · Feb 1993
DATASCOPE SYSTEM 95
K912629 · Datascope Corp. · Mar 1992
DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
K910997 · Datascope Corp. · Nov 1991
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
K905313 · Kontron Instruments, Inc. · Jun 1991
PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT
K905056 · Datascope Corp. · Jun 1991