Cleared Traditional

K172995 - Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

K172995 is an FDA 510(k) clearance for Destination Carotid Guiding Sheath, manufactured by Terumo Medical Corporation. 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.

K172995 · Terumo Medical Corporation · Cardiovascular device
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Nov 2017
Decision
55d
Days
Class 2
Risk

K172995 is an FDA 510(k) clearance for the Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, De.... Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on November 21, 2017 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.

View all Terumo Medical Corporation devices

FDA 510(k) Submission Details - K172995

510(k) Number K172995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2017
Decision Date November 21, 2017
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 646
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K172995.
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K171491 · Terumo Medical Corporation · Oct 2017