Cleared Traditional

K963104 - 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CO...

K963104 is an FDA 510(k) clearance for 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CO..., 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 179-day FDA review.

K963104 · Arrow Intl., Inc. · Cardiovascular device
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Feb 1997
Decision
179d
Days
Class 2
Risk

K963104 is an FDA 510(k) clearance for the 9.5 FR.- FLEXI-CATH INTRA-AORTIC AND CONTROL SYSTEM. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 179 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 - K963104

510(k) Number K963104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1996
Decision Date February 04, 1997
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
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 K963104.
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K965236 · Datascope Corp. · Jul 1997
8 FR.-30CC NARROWFLEX INTRA-AORTIC BALLOON CATHETER,
K963920 · Arrow Intl., Inc. · Jun 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
K964987 · Datascope Corp. · Mar 1997
INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED
K961509 · Datascope Corp. · Nov 1996
MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C
K963187 · Boston Scientific Corp · Nov 1996
BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT
K962177 · C.R. Bard, Inc. · Sep 1996