Cleared Special

K013326 - MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B

K013326 is an FDA 510(k) clearance for MODIFICATION TO: DATASCOPE 8FR. POLYIMI..., manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Special 510(k) pathway after a 28-day FDA review.

K013326 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
28d
Days
Class 2
Risk

K013326 is an FDA 510(k) clearance for the MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASC.... 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 November 2, 2001 after a review of 28 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.

FDA 510(k) Submission Details - K013326

510(k) Number K013326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2001
Decision Date November 02, 2001
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 156
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K013326.
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · Datascope Corp. · Jun 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
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256 · Arrow Intl., Inc. · May 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
K010330 · Arrow Intl., Inc. · Mar 2001
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
K003598 · Datascope Corp. · Dec 2000
K013326 · MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
Download PDF FDA Summary Datascope Corp.