Cleared Special

K122917 - CODA BALLOON CATHETER

K122917 is the FDA 510(k) clearance for CODA BALLOON CATHETER by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 276-day FDA review.

K122917 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
276d
Days
Class 2
Risk

K122917 is an FDA 510(k) clearance for the CODA BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on June 28, 2013 after a review of 276 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cook, Inc. devices

Submission Details

510(k) Number K122917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date June 28, 2013
Days to Decision 276 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
151d slower than avg
Panel avg: 125d · This submission: 276d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K122917.
SELECTRA ACCESSORY KIT, SELECTRA SLITTER TOOL
K131978 · Biotronik, Inc. · Aug 2013
AMPLATZER TORQ VUE LP DELIVERY SYSTEM
K131063 · St Jude Medical · Aug 2013
SIDEKICK AND USHER SUPPORT CATHETERS
K131493 · C.R. Bard, Inc. · Aug 2013
PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM
K122826 · Volcano Corporation · Apr 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252 · St Jude Medical · Mar 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257 · St Jude Medical · Mar 2013