Cleared Special

K150970 - Coda LP Balloon Catheter

K150970 is an FDA 510(k) clearance for Coda LP Balloon Catheter, manufactured by Cook Incorporated. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 29-day FDA review.

K150970 · Cook Incorporated · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
29d
Days
Class 2
Risk

K150970 is an FDA 510(k) clearance for the Coda LP Balloon Catheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 12, 2015 after a review of 29 days - a notably fast clearance 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. 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 - K150970

510(k) Number K150970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2015
Decision Date May 12, 2015
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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 861
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K150970.
Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
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K143608 · Nitiloop , Ltd. · May 2015
MicroCross Catheter
K143744 · Roxwood Medical, Inc. · Apr 2015
Silk Road Acccess Catheter
K143459 · Silk Road Medical, Inc. · Apr 2015
K150970 · Coda LP Balloon Catheter
Download PDF FDA Summary Cook Incorporated