Cleared Traditional

K122826 - PREVIEW FORWARD-LOOKING IVUS CATHETER A...

Also marketed or referenced as:
PREVIEW CATHETER MODEL 87000 PIMF MODEL 87-PIMF LAPTOP SYSTEM

K122826 is the FDA 510(k) clearance for PREVIEW FORWARD-LOOKING IVUS CATHETER A... by Volcano Corporation. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K122826 · Volcano Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
222d
Days
Class 2
Risk

K122826 is an FDA 510(k) clearance for the PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Volcano Corporation (Billerica, US). The FDA issued a Cleared decision on April 24, 2013 after a review of 222 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Volcano Corporation devices

Submission Details

510(k) Number K122826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2012
Decision Date April 24, 2013
Days to Decision 222 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
97d slower than avg
Panel avg: 125d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
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