Cleared Traditional

K802167 - PERCOR DATASCOPE INTRA-AORTIC BALLOON

K802167 is the FDA 510(k) clearance for PERCOR DATASCOPE INTRA-AORTIC BALLOON by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K802167 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1981
Decision
127d
Days
Class 2
Risk

K802167 is an FDA 510(k) clearance for the PERCOR DATASCOPE INTRA-AORTIC BALLOON. 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 January 13, 1981 after a review of 127 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 K802167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1980
Decision Date January 13, 1981
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 K802167.
MODEL 84 TRANSPORT SYSTEM
K811372 · Datascope Corp. · Aug 1981
DATASCOPE PERCOR=DL DUAL-LUMEN INTRA
K810297 · Datascope Corp. · May 1981
DATASCOPE/AVCO CONNECTOR
K801601 · Datascope Corp. · Jan 1981
INTRA-AORTIC BALLOON, TYPE S
K790775 · Datascope Corp. · Oct 1979
BALLOON PUMP
K780280 · Datascope Corp. · Mar 1978