Cleared Traditional

K951502 - CVD BULLET INFUSION CATYHETER

K951502 is an FDA 510(k) clearance for CVD BULLET INFUSION CATYHETER, manufactured by Cardiovascular Dynamics, Inc.. The device is a Class 2 Cardiovascular device with product code KRA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K951502 · Cardiovascular Dynamics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
43d
Days
Class 2
Risk

K951502 is an FDA 510(k) clearance for the CVD BULLET INFUSION CATYHETER. 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 10, 1995 after a review of 43 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.

FDA 510(k) Submission Details - K951502

510(k) Number K951502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1995
Decision Date May 10, 1995
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRA Device Classification - Class 2, Special Controls

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 173
Devices cleared under the same product code (KRA) and FDA review panel - the closest regulatory comparables to K951502.
PULSE*SPRAY INFUSION SYSTEM
K951602 · Angiodynamics, Div. E-Z-Em, Inc. · Jun 1995
NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER
K945909 · Navarre Biomedical , Ltd. · Jun 1995
SCIMED(R) VENTURE(TM) II INFUSION CATHETER
K945904 · Scimed Peripheral Interventions · May 1995
CVD BULLETT HI-FLO INFUSION CATHETER
K951503 · Cardiovascular Dynamics, Inc. · May 1995
SCIMED(R) CORONARY GUIDE WIRE EXCHANGE/INFUSION CATHETER
K945593 · Scimed Life Systems, Inc. · Jan 1995
LOCALMED INFUSION CATHETER
K935349 · Localmed, Inc. · Oct 1994
K951502 · CVD BULLET INFUSION CATYHETER
Download PDF FDA Summary Cardiovascular Dynami…