Cleared Special

K052717 - D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER

K052717 is an FDA 510(k) clearance for D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIA..., manufactured by Dideco S.R.L.. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Special 510(k) pathway after a 21-day FDA review.

K052717 · Dideco S.R.L. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
21d
Days
Class 2
Risk

K052717 is an FDA 510(k) clearance for the D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Dideco S.R.L. (Waltham, US). The FDA issued a Cleared decision on October 20, 2005 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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 - K052717

510(k) Number K052717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date October 20, 2005
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 95
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K052717.
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
K063255 · Sorin Group Italia S.R.L. · Jan 2007
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
K062429 · Edwards Lifesciences Research Medical · Sep 2006
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
K061546 · Maquet Cardiopulmonary, AG · Jun 2006
CAPIOX AF125X ARTERIAL FILTER
K052205 · Terumo Cardiovascular Systems Corp. · Sep 2005
D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER
K051232 · Dideco S.R.L. · May 2005
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
K041061 · Dideco S.P.A. · May 2004
K052717 · D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
Download PDF FDA Summary Dideco S.R.L.