Cleared Traditional

K120781 - CELLO BALLOON GUIDE CATHETER (6F)

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)
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.

View all Fuji Systems Corp. devices

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
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 651
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K120781.
TYSHAK NUCLEUS
K121859 · NuMED, Inc. · Aug 2012
RUBICON 18 SUPPORT CATHETER
K122394 · Boston Scientific Corp · Aug 2012
ARMADA 14XXT PTA CATHETER
K121352 · Abbott Vascular · Aug 2012
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
K121839 · LeMaitre Vascular, Inc. · Aug 2012
CONCIERGE GUIDING CATHETER
K121051 · Merit Medical Systems, Inc. · Jun 2012
SWITCH-IT CATHETER
K120707 · Vascular Solutions, Inc. · May 2012