Cleared Traditional

K042376 - ACUMEN SHEATH, MODEL TTW7807

K042376 is an FDA 510(k) clearance for ACUMEN SHEATH, manufactured by Acumen Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K042376 · Acumen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
55d
Days
Class 2
Risk

K042376 is an FDA 510(k) clearance for the ACUMEN SHEATH, MODEL TTW7807. 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 October 26, 2004 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042376

510(k) Number K042376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2004
Decision Date October 26, 2004
Days to Decision 55 days
Submission Type Traditional
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
70d faster than avg
Panel avg: 125d · This submission: 55d
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 686
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K042376.
AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304
K042623 · St. Jude Medical, Daig Division, Inc. · Jan 2005
MODIFICATION TO SHORT INTRODUCER SHEATH
K042399 · Rex Medical, L.P. · Dec 2004
ENPATH SAFETY INTRODUCER
K041708 · Enpath Medical Incorporated · Nov 2004
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
K042376 · ACUMEN SHEATH, MODEL TTW7807
Download PDF FDA Summary Acumen Medical, Inc.