Cleared Special

K050015 - MODIFIED ACUMEN SHEATH, MODEL TTWO767

K050015 is an FDA 510(k) clearance for MODIFIED ACUMEN SHEATH, manufactured by Acumen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 30-day FDA review.

K050015 · Acumen Medical, Inc. · Cardiovascular device
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Feb 2005
Decision
30d
Days
Class 2
Risk

K050015 is an FDA 510(k) clearance for the MODIFIED ACUMEN SHEATH, MODEL TTWO767. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Acumen Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on February 3, 2005 after a review of 30 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K050015

510(k) Number K050015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2005
Decision Date February 03, 2005
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 505
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K050015.
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
LARGE BORE SPLITTABLE INTRODUCER KIT
K043438 · Thomas Medical Products, Inc. · Feb 2005
INTRAVASCULAR ACCESS INTRODUCER SHEATH
K041506 · Applied Medical Resources Corp. · Oct 2004
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc. · Aug 2004
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT
K040728 · AngioDynamics, Inc. · Jun 2004