Cleared Traditional

8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODUCT NUMBER IAB-04840(USED WITH A 9FR.SHEATH) (K960713) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960713 · Arrow Intl., Inc. · Cardiovascular device
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May 1996
Decision
84d
Days
Class 2
Risk

K960713 is an FDA 510(k) clearance for the 8 FR.-40CC ARROW FLEX INTRA-AORTIC BALLOON CATHETER WITH BLUE FLEX TIP, PRODU.... 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 May 15, 1996 after a review of 84 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arrow Intl., Inc. devices

Submission Details

510(k) Number K960713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1996
Decision Date May 15, 1996
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 90
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K960713.
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