Cleared Traditional

K081697 - THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006

K081697 is an FDA 510(k) clearance for THE WAND MICROACCESS SAFETY INTRODUCER, manufactured by Access Scientific, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K081697 · Access Scientific, Inc. · Cardiovascular device
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Dec 2008
Decision
170d
Days
Class 2
Risk

K081697 is an FDA 510(k) clearance for the THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Access Scientific, Inc. (San Diego, US). The FDA issued a Cleared decision on December 4, 2008 after a review of 170 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Access Scientific, Inc. devices

FDA 510(k) Submission Details - K081697

510(k) Number K081697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date December 04, 2008
Days to Decision 170 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
45d slower than avg
Panel avg: 125d · This submission: 170d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 491
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K081697.
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