Cleared Special

K052791 - MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

K052791 is an FDA 510(k) clearance for MODIFICATION TO: AMPHIRION DEEP 0.014 O..., 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 32-day FDA review.

K052791 · 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
Nov 2005
Decision
32d
Days
Class 2
Risk

K052791 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 November 4, 2005 after a review of 32 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 - K052791

510(k) Number K052791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date November 04, 2005
Days to Decision 32 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
93d faster than avg
Panel avg: 125d · This submission: 32d
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
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K052791 · MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
Download PDF FDA Summary Invatec Innovative Te…