Cleared Traditional

CVD BULLETT HI-FLO INFUSION CATHETER (K951503) - FDA 510(k) Clearance

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

K951503 · Cardiovascular Dynamics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
37d
Days
Class 2
Risk

K951503 is an FDA 510(k) clearance for the CVD BULLETT HI-FLO INFUSION CATHETER. Classified as Catheter, Continuous Flush (product code KRA), Class II - Special Controls.

Submitted by Cardiovascular Dynamics, Inc. (Irvine, US). The FDA issued a Cleared decision on May 4, 1995 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1210 - 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 Cardiovascular Dynamics, Inc. devices

Submission Details

510(k) Number K951503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1995
Decision Date May 04, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRA Catheter, Continuous Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1210
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 - KRA Catheter, Continuous Flush

All 65
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K951503.
INTRAVASCULAR INFUSION DEVICE
K963988 · Boston Scientific Corp · Dec 1996
MICROFERRET CATHETER
K961668 · Cook, Inc. · Nov 1996
EVOLUTION(TM) MICROCATHETER
K945666 · Boston Scientific Corp · Jun 1995
SAFESET RESERVOIR
K932188 · Abbott Laboratories · Oct 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · Baxter Healthcare Corp · Apr 1993
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K896819 · Baxter Healthcare Corp · Jan 1990