Cleared Special

K051515 - MODIFIED ACUMEN SHEATH, MODEL TTW 10-65

K051515 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 85-day FDA review.

K051515 · Acumen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
85d
Days
Class 2
Risk

K051515 is an FDA 510(k) clearance for the MODIFIED ACUMEN SHEATH, MODEL TTW 10-65. 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 September 1, 2005 after a review of 85 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.

FDA 510(k) Submission Details - K051515

510(k) Number K051515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2005
Decision Date September 01, 2005
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 686
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K051515.
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · St Jude Medical · Dec 2005
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248 · Vygon Corp. · Oct 2005
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
INNER-LOCK INTRODUCER SHEATH
K051468 · Rex Medical · Aug 2005
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K051601 · Terumo Medical Corp. · Aug 2005
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
K051096 · St. Jude Medical, Daig Division, Inc. · May 2005
K051515 · MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
Download PDF FDA Summary Acumen Medical, Inc.