Cleared Traditional

K090977 - PIGGYBACK WIRE CONVERTER

K090977 is the FDA 510(k) clearance for PIGGYBACK WIRE CONVERTER by Vascular Solutions, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K090977 · Vascular Solutions, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
73d
Days
Class 2
Risk

K090977 is an FDA 510(k) clearance for the PIGGYBACK WIRE CONVERTER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Vascular Solutions, Inc. (Minneapolis, US). The FDA issued a Cleared decision on June 18, 2009 after a review of 73 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascular Solutions, Inc. devices

Submission Details

510(k) Number K090977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2009
Decision Date June 18, 2009
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 552
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K090977.
MODIFICATION TO MODIFIED HD GUIDE CATHETER
K092298 · Concentric Medical, Inc. · Nov 2009
HEADWAY 21 MICROCATHETER, MODEL: MC212150S
K093160 · MicroVention, Inc. · Nov 2009
GUIDELINER CATHETER, MODELS 5571, 5572, 5573
K091750 · Vascular Solutions, Inc. · Nov 2009
GOPHER GOLD CATHETER, MODEL 5620
K091345 · Vascular Solutions, Inc. · Jun 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
K091527 · Cook, Inc. · Jun 2009
HD GUIDE CATHETER
K090335 · Concentric Medical, Inc. · May 2009