Cleared Special

K050073 - MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

K050073 is an FDA 510(k) clearance for MODIFICATION TO AMPHIRION DEEP 0.014 OT..., manufactured by Invatec Innovative Technologies, S.R.L.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 30-day FDA review.

K050073 · Invatec Innovative Technologies, S.R.L. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
30d
Days
Class 2
Risk

K050073 is an FDA 510(k) clearance for the MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Invatec Innovative Technologies, S.R.L. (Plymouth, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050073

510(k) Number K050073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2005
Decision Date February 11, 2005
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 878
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K050073.
ALLIGATOR RETRIEVAL DEVICE (ARD)
K043580 · Chestnut Medical Technologies, Inc. · Mar 2005
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
K042553 · Biocardia, Inc. · Feb 2005
VASCON POLARIS GUIDING CATHETER
K043387 · Vascon, LLC · Feb 2005
MODIFICATION TO OUTBACK CATHETER
K043534 · Lumend, Inc. · Jan 2005
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
K042624 · Invatec Innovative Technologies, S.R.L. · Jan 2005
PROXIS SYSTEM, MODEL EPS 101
K042117 · Velocimed, Inc. · Jan 2005
K050073 · MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Download PDF FDA Summary Invatec Innovative Te…