510(k) · Cleared
Recalled · Class II · 2023CV Peri-Guard and Vascu-Guard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Vascular, Inc. · DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cleared on Nov 12, 1998 as substantially equivalent to K971726 (Bio-Vascular, Inc., 1998) and 3 other predicates after a 30-day review. Its family tree reaches back 2 generations to 1992. 2 of the 37 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 12, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- DXZ
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 2 generations to K921895 (1992). 5 ancestors in all. 31 later devices descend from it, 10 citing it directly. 2 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 1 generation backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- This deviceK983602 CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 1998
- Descendant · cites it directly · 24 of its ownK040415 Peri-Strips Staple Line Reinforcement - Sleeve and Strip…Synovis Surgical Innovations · 2004 · Recalled
- 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 · 2 generations on · 4 of its ownK041669 Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 2004 · Recalled
- Descendant · 3 generations on · 3 of its ownK173242 CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo…Aziyo Biologics, Inc. · 2017 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K040415Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and…Synovis Surgical Innovations · 2004 · cites it directly24descendants
- K063349Cormatrix Patch for Cardiac Tissue RepairCormatrix Cardiovascular, Inc. · 2007 · cites it directly11descendants
- K140306Cormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. · 2014 · 2 generations on4descendants
- K041669Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSynovis Surgical Innovations · 2004 · 2 generations on4descendants
- K173242CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large)…Aziyo Biologics, Inc. · 2017 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −1 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| 0 (this device) | K983602 | CV Peri-Guard and Vascu-Guard | Bio-Vascular, Inc. | 1998 | — |
| +1 | K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and… | Synovis Surgical Innovations | 2004 | 1 |
| +1 | K063349 | Cormatrix Patch for Cardiac Tissue Repair | Cormatrix Cardiovascular, Inc. | 2007 | — |
| +2 | K140306 | Cormatrix Protect Ecm Envelope | Cormatrix Cardiovascular, Inc. | 2014 | 2 |
| +2 | K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSD | Synovis Surgical Innovations | 2004 | 8 |
| +3 | K173242 | CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope… | Aziyo Biologics, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 1 |
| 2013 | 1 | 0 |
| 2014 | 4 | 1 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
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.
2 devices in this family have a Class I recall. 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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K971726 | CV Peri-Guard - Cardiovascular PatchSummary page 1…mber 9, 1998 Common or Usual Name: CV Peri-Guard™ Cardiovascular Patch Device Classification Name: Intracardiac patch or pledget Substantial Equivalence: CV Peri-Guard K971726 Device Description: CV Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Statement of I… | 1998 |
| * | K942010 | Vascu-GuardSummary page 2…ber 9, 1998 Common or Usual Name: Vascu-Guard® Peripheral Vascular Patch Device Classification Name: Intracardiac patch or pledget Substantial Equivalence: Vascu-Guard K942010 Device Description: Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Statement of Int… | 1994 |
| * | K961810 | Supple Peri-Guard PericardiumSummary page 3…September 9, 1998 Common or Usual Name: Supple Peri-Guard® Pericardium Device Classification Name: Mesh, surgical, polymeric Substantial Equivalence: Supple Peri-Guard K961810, K921895 Device Description: Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. S… | 1996 |
| * | K921895 | Tissue Patch, Tissue GraftSummary page 3…9, 1998 Common or Usual Name: Supple Peri-Guard® Pericardium Device Classification Name: Mesh, surgical, polymeric Substantial Equivalence: Supple Peri-Guard K961810, K921895 Device Description: Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Statement… | 1992 |
What descends from it? (31)
See all 3110 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and… | 2004 | 24 |
| K063349 | Cormatrix Patch for Cardiac Tissue Repair | 2007 | 11 |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | 2015 | 1 |
| K142461 | VASCU-GUARD Peripheral Vascular Patch Class I | 2014 | 1 |
| K111187 | Patch, Pledget and Intracardiac | 2011 | 1 |
| K031785 | Macropore Cardio-Wrap (TS) | 2003 | 1 |
| K221029 | PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch | 2022 | 0 |
| K221032 | Vascu-Guard Vascular Repair Patch | 2022 | 0 |
| K140789 | Cormatrix Ecm for Vascular Repair | 2014 | 0 |
| K090637 | Cardio-Wrap | 2010 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2023 | Class II | Z-0669-2024 | Under Investigation by firm | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information… |
| Jun 24, 2016 | Class II | Z-2533-2016 | Under Investigation by firm | Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional… |
| Oct 28, 2013 | Class II | Z-0338-2014 | Packaging change control | Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 3.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K040415 (Synovis Surgical Innovations, 2004) has gone furthest, with 24 descendants of its own.
- 3 other devices also cite its predicate K971726.
How does its category compare?
All DXZ devicesDXZ 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DXZ
106in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXZ
2in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · DXZ
119in 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?
CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing. Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions. Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of…
Read the full statement (104 words)
CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Supple Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hemias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983602 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983602: CV Peri-Guard and Vascu-Guard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983602
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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