510(k) · Cleared

Cleared

Ptfe Felts and Pledgets

K041716510(k) SpecialCleared Jul 22, 200428-day reviewClass II21 CFR 870.3470

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Boston Scientific Corp · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Cleared on Jul 22, 2004 after a 28-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided: Jul 22, 2004
Review: 28 days
Class: Class II
Product code: DXZ
Recalls: None
Predicates: 0

13 later devices descend from it, 2 citing it directly.

This deviceK041716 Ptfe Felts and PledgetsBoston Scientific Corp · 2004
Descendant · cites it directly · 11 of its ownK063349 Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007
Descendant · 2 generations on · 4 of its ownK140306 Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · Recalled
Descendant · 3 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
Descendant · 4 generations on · 2 of its ownK182255 CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium)…Aziyo Biologics, Inc. · 2018 · Recalled
Descendant · 2 generations on · 2 of its ownK152127 CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2007high 2 (2014) · low 0 (2009)2026

Most influential descendants

Showing 5 of 13 · See all

K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · cites it directly11descendants
K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 2 generations on4descendants
K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 3 generations on3descendants
K182255CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro…Aziyo Biologics, Inc. · 2018 · 4 generations on2descendants
K152127CorMatrix TykeCormatrix Cardiovascular, Inc. · 2016 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K041716	Ptfe Felts and Pledgets	Boston Scientific Corp	2004	—
+1	K063349	Cormatrix Patch for Cardiac Tissue Repair	Cormatrix Cardiovascular, Inc.	2007	—
+2	K140306	Cormatrix Protect Ecm Envelope	Cormatrix Cardiovascular, Inc.	2014	2
+3	K173242	CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope…	Aziyo Biologics, Inc.	2017	1
+4	K182255	CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo…	Aziyo Biologics, Inc.	2018	1
+2	K152127	CorMatrix Tyke	Cormatrix Cardiovascular, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2011	1	0
2014	2	0
2015	1	0
2016	1	0
2017	1	0
2018	2	0
2019	1	0
2020	1	0
2021	1	0

FIG. 1 — Lineage of K041716, 2004–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXZ device

#1 K240775 PeriBeam® Pericardial Membranescore 9.2 · 1 generation · no Class I recall
#2 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	PTFE Felts and Pledgets (Preamendment devices) Named without a submission number			—

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063349	Cormatrix Patch for Cardiac Tissue Repair	Cormatrix Cardiovascular, Inc.	2007	11
K151865	PremiPatch PTFE Pledget	Aesculap, Inc.	2015	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K063349 (Cormatrix Cardiovascular, Inc., 2007) has gone furthest, with 11 descendants of its own.

How does its category compare?

All DXZ devices

DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXZ

1in 2025

2007high 3 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXZ

106in 2014

2007high 106 (2014) · low 91 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXZ

2in 2025

2007high 2 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · DXZ

119in 2025

2007high 171 (2015) · low 6 (2008)2025

MAUDE reports naming product code DXZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	0	50
2008	2	—	0	6
2009	1	—	0	109
2010	3	91	2	81
2011	2	—	2	47
2012	1	—	0	21
2013	1	—	2	69
2014	3	106	0	93
2015	2	—	0	171
2016	2	—	0	66
2017	1	—	0	30
2018	0	—	1	44
2019	0	—	0	55
2020	1	—	1	121
2021	0	—	0	80
2022	0	—	0	77
2023	0	—	2	40
2024	0	—	0	49
2025	1	—	2 (2)	119
2026	0	—	1	—

What is it indicated for?

Felts:

Indicated for Ventricular aneurysmectomy; tissue prosthesis, and suture buttressing.

Pledgets: Indicated for Tissue, prosthesis, and suture buttressing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041716 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041716: Ptfe Felts and Pledgets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041716

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026