Cleared Traditional

K070865 - EXPANDING VASCULAR SHEATH

K070865 is an FDA 510(k) clearance for EXPANDING VASCULAR SHEATH, manufactured by Applied Medical. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K070865 · Applied Medical · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2007
Decision
208d
Days
Class 2
Risk

K070865 is an FDA 510(k) clearance for the EXPANDING VASCULAR SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Applied Medical (Rancho Santa, US). The FDA issued a Cleared decision on October 23, 2007 after a review of 208 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 Applied Medical devices

FDA 510(k) Submission Details - K070865

510(k) Number K070865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2007
Decision Date October 23, 2007
Days to Decision 208 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 125d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 433
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K070865.
CONVOY ADVANCED DELIVERY SHEATH
K072719 · Boston Scientific Corp · Mar 2008
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K080415 · Terumo Medical Corp. · Mar 2008
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
K073100 · Oscor, Inc. · Nov 2007
INTRAVASCULAR INTRODUCER SYSTEM
K063658 · Applied Medical Resources Corp. · Sep 2007
ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984
K070417 · St Jude Medical · Jun 2007
STRADA CAROTID GUIDING SHEATH
K070166 · St Jude Medical · Apr 2007