Cleared Special

K031569 - DATASCOPE CA 40 8FR. IABS

K031569 is the FDA 510(k) clearance for DATASCOPE CA 40 8FR. IABS by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Special 510(k) pathway after a 21-day FDA review.

K031569 · Datascope Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2003
Decision
21d
Days
Class 2
Risk

K031569 is an FDA 510(k) clearance for the DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on June 10, 2003 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datascope Corp. devices

Submission Details

510(k) Number K031569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2003
Decision Date June 10, 2003
Days to Decision 21 days
Submission Type Special
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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 K031569.
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
K041281 · Datascope Corp. · Jun 2004
INTRA-AORTIC BALLOON (IAB)
K040801 · Arrow Intl., Inc. · May 2004
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
K031636 · Datascope Corp. · Aug 2003
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
K021462 · Arrow Intl., Inc. · Jun 2002
DATASCOPE'S 8FR. ALT B IAB
K020257 · Datascope Corp. · Apr 2002
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
K013326 · Datascope Corp. · Nov 2001