Cleared Traditional

K940231 - INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION

K940231 is an FDA 510(k) clearance for INTRA-AORTIC BALLOON FOR OPTIONAL SHEAT..., 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 238-day FDA review.

K940231 · Datascope Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 1994
Decision
238d
Days
Class 2
Risk

K940231 is an FDA 510(k) clearance for the INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION. 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 September 13, 1994 after a review of 238 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 - K940231

510(k) Number K940231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1994
Decision Date September 13, 1994
Days to Decision 238 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 125d · This submission: 238d
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 K940231.
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
K935184 · St. Jude Medical, Inc. · Feb 1995
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K944460 · Datascope Corp. · Dec 1994
BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER
K936232 · Boston Scientific Corp · Oct 1994
PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION
K940178 · Datascope Corp. · Aug 1994
MODIFICATIONS TO INTRA-AORTIC BALLOONS
K932268 · Kontron Instruments, Inc. · Dec 1993
MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS
K925248 · Kontron Instruments, Inc. · Sep 1993