Cleared Traditional

K963865 - 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA...

K963865 is an FDA 510(k) clearance for 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA..., 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 357-day FDA review.

K963865 · Arrow Intl., Inc. · Cardiovascular device
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Sep 1997
Decision
357d
Days
Class 2
Risk

K963865 is an FDA 510(k) clearance for the 8 FR. -30CC NARROWFLEX SHEATHLESS INTRA-AORTIC BALLOON CATHETER, PRODUCT NUMB.... 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 September 16, 1997 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K963865

510(k) Number K963865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1996
Decision Date September 16, 1997
Days to Decision 357 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
232d slower than avg
Panel avg: 125d · This submission: 357d
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 K963865.
BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS
K973962 · C.R. Bard, Inc. · Feb 1998
40 CC GRANDE
K974247 · Boston Scientific Corp · Feb 1998
ACAT 1 (ARROW CARDIAC ASSIST TECHNOLOGY 1)
K965209 · Arrow Intl., Inc. · Jan 1998
30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL
K972113 · Boston Scientific Corp · Sep 1997
40 CC SUMO
K971673 · Boston Scientific Corp · Aug 1997
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K965236 · Datascope Corp. · Jul 1997