Cleared Traditional

K122826 - PREVIEW FORWARD-LOOKING IVUS CATHETER AND LAPTOP SYSTEM

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

K122826 is an FDA 510(k) clearance for PREVIEW FORWARD-LOOKING IVUS CATHETER A..., manufactured by Volcano Corporation. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K122826

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.

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 781
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