Cleared Special

K080500 - MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7

K080500 is an FDA 510(k) clearance for MODIFICATION TO: ACUMEN SINGLE-LUMEN DE..., 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 17-day FDA review.

K080500 · Acumen Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
17d
Days
Class 2
Risk

K080500 is an FDA 510(k) clearance for the MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, B.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Acumen Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 13, 2008 after a review of 17 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 - K080500

510(k) Number K080500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2008
Decision Date March 13, 2008
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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 K080500.
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K081046 · Terumo Medical Corp. · May 2008
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
K081341 · Thomas Medical Products, Inc. · May 2008
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
K073434 · Bipore, Inc. · Apr 2008
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
K080500 · MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
Download PDF FDA Summary Acumen Medical, Inc.