Cleared Special

K040867 - PERIVAC KIT

K040867 is the FDA 510(k) clearance for PERIVAC KIT by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Special 510(k) pathway after a 28-day FDA review.

K040867 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
28d
Days
Class 2
Risk

K040867 is an FDA 510(k) clearance for the PERIVAC KIT, MODELS 4304, 4305, 4314, 4315. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on April 30, 2004 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K040867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2004
Decision Date April 30, 2004
Days to Decision 28 days
Submission Type Special
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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 498
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K040867.
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531 · Asahi Intecc Co., Ltd. · Aug 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624 · Lake Region Mfg., Inc. · Jul 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
K040825 · Lake Region Mfg., Inc. · May 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345 · Ev3, Inc. · Mar 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100 · Arrow Intl., Inc. · Mar 2004
IQ GUIDE WIRE
K040140 · Boston Scientific Corp · Feb 2004