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
Download Printable Device Report (PDF)
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
Combination Product No
PCCP Authorized No
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 Consultant

Underwriters Laboratories, Inc.
MORTEN SIMON CHRISTENSEN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DYB Introducer, Catheter

All 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K070865.
INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S
K073100 · Oscor, Inc. · Nov 2007
VIAPEEL PEELABLE INTRODUCER
K072248 · Enpath Medical, Inc. · Nov 2007
PTFE PEEL AWAY MICROINTRODUCER
K072130 · Intromed · Oct 2007
PERIPHERAL GUIDING SHEATH
K070816 · Micrus Design Technology, Inc. · Sep 2007
INTRAVASCULAR INTRODUCER SYSTEM
K063658 · Applied Medical Resources Corp. · Sep 2007
STIFFER COAXIAL MICRO-INTRODUCER KIT
K071574 · Enpath Medical, Inc. · Jul 2007