Cleared Traditional

K945230 - ARROW KINK RESISTANT FLEXI-CATH INTRA-A...

K945230 is an FDA 510(k) clearance for ARROW KINK RESISTANT FLEXI-CATH INTRA-A..., 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 195-day FDA review.

K945230 · Arrow Intl., Inc. · Cardiovascular device
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May 1995
Decision
195d
Days
Class 2
Risk

K945230 is an FDA 510(k) clearance for the ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON. 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 9, 1995 after a review of 195 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 - K945230

510(k) Number K945230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1994
Decision Date May 09, 1995
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
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 K945230.
PERCOR STAT-DL 9.5 FR. 34 & 40CC
K960166 · Datascope Corp. · Apr 1996
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
K954431 · Boston Scientific Corp · Jan 1996
BSC/CA 30 & 40 SENSATION, MODELS 930 & 940
K952221 · Boston Scientific Corp · Aug 1995
BSC/CA MODEL 940 IAB
K940298 · Boston Scientific Corp · Apr 1995
9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER
K943919 · Boston Scientific Corp · Mar 1995
DATASCOPE 95 AND 97 IAB PUMP CONSOLE
K942454 · Datascope Corp. · Feb 1995