Cleared Special

K162769 - Pinpoint GT Introducer Needle

K162769 is an FDA 510(k) clearance for Pinpoint GT Introducer Needle, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Special 510(k) pathway after a 32-day FDA review.

K162769 · C.R. Bard, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2016
Decision
32d
Days
Class 2
Risk

K162769 is an FDA 510(k) clearance for the Pinpoint GT Introducer Needle. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on November 4, 2016 after a review of 32 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 - K162769

510(k) Number K162769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2016
Decision Date November 04, 2016
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
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 662
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K162769.
Vado Bi-Directional Steerable Sheath
K162427 · Kalila Medical, Inc. · Jan 2017
InTRAkit
K162097 · Medtronic Vascular · Nov 2016
the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model
K162322 · Access Scientific, LLC · Nov 2016
TXM Guiding Sheath
K153771 · Texasmedical Technologies, Inc. · Sep 2016
Edwards eSheath Introducer Set
K162184 · Edward Lifesciences · Sep 2016
HQS Introducer (Model 2064-HQS)
K153494 · Alseal · Aug 2016