Cleared Traditional

K120781 - CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH

K120781 is an FDA 510(k) clearance for CELLO BALLOON GUIDE CATHETER (6F), manufactured by Fuji Systems Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K120781 · Fuji Systems Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
147d
Days
Class 2
Risk

K120781 is an FDA 510(k) clearance for the CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Fuji Systems Corp. (San Diego, US). The FDA issued a Cleared decision on August 9, 2012 after a review of 147 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K120781

510(k) Number K120781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2012
Decision Date August 09, 2012
Days to Decision 147 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
22d slower than avg
Panel avg: 125d · This submission: 147d
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 855
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K120781.
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