Cleared Special

K052185 - DESTINATION CAROTID GUIDING SHEATH

K052185 is an FDA 510(k) clearance for DESTINATION CAROTID GUIDING SHEATH, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 26-day FDA review.

K052185 · Terumo Medical Corp. · Cardiovascular device
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Sep 2005
Decision
26d
Days
Class 2
Risk

K052185 is an FDA 510(k) clearance for the DESTINATION CAROTID GUIDING SHEATH. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on September 6, 2005 after a review of 26 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K052185

510(k) Number K052185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2005
Decision Date September 06, 2005
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 438
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K052185.
INTRODUCER ASSEMBLY WITH ROTATOR LOCK
K060519 · Teleflex Medical · May 2006
SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
K052644 · St Jude Medical · Dec 2005
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
K051248 · Vygon Corp. · Oct 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