Cleared Special

K000729 - ARROW ULTRA 8 INTRA-AORTIC BALLOON CATH...

K000729 is an FDA 510(k) clearance for ARROW ULTRA 8 INTRA-AORTIC BALLOON CATH..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Special 510(k) pathway after a 74-day FDA review.

K000729 · Arrow Intl., Inc. · Cardiovascular device
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May 2000
Decision
74d
Days
Class 2
Risk

K000729 is an FDA 510(k) clearance for the ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL. 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 19, 2000 after a review of 74 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K000729

510(k) Number K000729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2000
Decision Date May 19, 2000
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
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 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K000729.
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
DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329
K994157 · Datascope Corp. · Mar 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966 · Arrow Intl., Inc. · Feb 2000
Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters
K981660 · C.R. Bard, Inc. · Oct 1998