Not Cleared Traditional

K910997 - DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON

K910997 is an FDA 510(k) submission for DATASCOPE PERCOR STAT 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 242-day FDA review.

K910997 · Datascope Corp. · Cardiovascular device
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Nov 1991
Decision
242d
Days
Class 2
Risk

K910997 is an FDA 510(k) submission (not cleared) for the DATASCOPE PERCOR STAT 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 Not Cleared (DENG) decision on November 5, 1991 after a review of 242 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

FDA 510(k) Submission Details - K910997

510(k) Number K910997 FDA.gov
FDA Decision Not Cleared SI (SI)
Date Received March 08, 1991
Decision Date November 05, 1991
Days to Decision 242 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
117d slower than avg
Panel avg: 125d · This submission: 242d
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 156
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K910997.
BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP
K915580 · Belmont Instrument Corp. · Oct 1992
DATASCOPE SYSTEM 95
K912629 · Datascope Corp. · Mar 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · Datascope Corp. · Mar 1992
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
COMPACT MONITOR SMK 210,211,230,231,240
K903917 · Ppg Hellige B.V. · Jan 1991
K910997 · DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON
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