Cleared Traditional

K002256 - ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP

K002256 is an FDA 510(k) clearance for ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K002256 · Arrow Intl., Inc. · Cardiovascular device
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May 2001
Decision
282d
Days
Class 2
Risk

K002256 is an FDA 510(k) clearance for the ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Everett, US). The FDA issued a Cleared decision on May 3, 2001 after a review of 282 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K002256

510(k) Number K002256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2000
Decision Date May 03, 2001
Days to Decision 282 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
157d slower than avg
Panel avg: 125d · This submission: 282d
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 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K002256.
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
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
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949 · Datascope Corp. · Oct 2000