Cleared Traditional

K051601 - PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

K051601 is an FDA 510(k) clearance for PINNACLE DESTINATION PERIPHERAL GUIDING..., manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K051601 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
49d
Days
Class 2
Risk

K051601 is an FDA 510(k) clearance for the PINNACLE DESTINATION PERIPHERAL 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 August 4, 2005 after a review of 49 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 Corp. devices

FDA 510(k) Submission Details - K051601

510(k) Number K051601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2005
Decision Date August 04, 2005
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 648
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K051601.
DESTINATION CAROTID GUIDING SHEATH
K052185 · Terumo Medical Corp. · Sep 2005
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
K051515 · Acumen Medical, Inc. · Sep 2005
INNER-LOCK INTRODUCER SHEATH
K051468 · Rex Medical · Aug 2005
APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582
K051096 · St. Jude Medical, Daig Division, Inc. · May 2005
PREMERE DELIVERY SHEATH, MODEL PDS
K043084 · Velocimed, Inc. · May 2005
SECURELOC
K050023 · Specialized Health Products, Inc. · Feb 2005