Cleared Traditional

K905056 - PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT

K905056 is an FDA 510(k) clearance for PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O ..., 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 215-day FDA review.

K905056 · Datascope Corp. · Cardiovascular device
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Jun 1991
Decision
215d
Days
Class 2
Risk

K905056 is an FDA 510(k) clearance for the PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT. 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 June 11, 1991 after a review of 215 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 - K905056

510(k) Number K905056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1990
Decision Date June 11, 1991
Days to Decision 215 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
90d slower than avg
Panel avg: 125d · This submission: 215d
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 K905056.
SYSTEM 90 AND SYSTEM 90T
K913847 · 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
9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)
K903344 · Kontron Instruments, Inc. · Jan 1991
DATASCOPE PERCOR STAT DL 10.5 FR 50CC
K903930 · Datascope Corp. · Nov 1990
DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS
K904414 · Datascope Corp. · Oct 1990