Cleared Traditional

K810297 - DATASCOPE PERCOR=DL DUAL-LUMEN INTRA

K810297 is an FDA 510(k) clearance for DATASCOPE PERCOR=DL DUAL-LUMEN INTRA, 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 90-day FDA review.

K810297 · Datascope Corp. · Cardiovascular device
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May 1981
Decision
90d
Days
Class 2
Risk

K810297 is an FDA 510(k) clearance for the DATASCOPE PERCOR=DL DUAL-LUMEN INTRA. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on May 6, 1981 after a review of 90 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 - K810297

510(k) Number K810297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date May 06, 1981
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K810297.
DATASCOPE MODIFIED #82 IABP SYSTEM
K813182 · Datascope Corp. · Mar 1982
FUKUDA DENSHI CARDIMAX FK-11
K813023 · Brentwood Instruments, Inc. · Dec 1981
MODEL 84 TRANSPORT SYSTEM
K811372 · Datascope Corp. · Aug 1981
DATASCOPE/AVCO CONNECTOR
K801601 · Datascope Corp. · Jan 1981
PERCOR DATASCOPE INTRA-AORTIC BALLOON
K802167 · Datascope Corp. · Jan 1981
INTRA-AORTIC BALLOON, TYPE S
K790775 · Datascope Corp. · Oct 1979