510(k) K082139
- Device
- EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
- Applicant
- EDWARDS LIFESCIENCES, LLC.
- 510(k) number
- K082139
- Product code
- DXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-23
- Date received
- 2008-07-29
- Regulation
- 870.3470
- Classification name
- Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DARYL RICHARDSON
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 1614993
- 1018470
- 1640201
- 2024024
- 3007791599
- 2015691
- 3005064037
- 1526611
- 3007284313
- 1060680
- 2320762
- 1043214
- 1450662
- 2210968
- 3005381997
- 3010452421
- 3017102971
- 3031160994
- 1220948
- 1055236
- 3005636544
- 2648650
- 3003639970
- 2020394
- 1221601
- 3006017180
- 1416980
- 3004681519
- 3002924436
- 1063481
- 3006638824
- 9680759
- 2183620
- 1000393132
- 1047843
- 9612501
- 3018094310
- 3009672666
- 3010407203
- 1647149
- 3006082230
- 3011137372
- 3019716369
- 1018233
- 3010162973
- 1054241
- 1649139
- 1835959
- 3002719998
- 1282497
- 3041851334
- 3010041511
- 9612515
- 3004365956
- 3010097171
Source Documents#
Other 510(k) Records For Product Code DXZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240775 | PeriBeam® Pericardial Membrane | Tamabio | 2025-04-18 |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch | Vascutek, Ltd. | 2020-07-08 |
| K162506 | PhotoFix Decellularized Bovine Pericardium | Cryolife, Inc. | 2017-03-09 |
| K162579 | VascuCel | Admedus Regen Pty, Ltd. | 2016-10-14 |
| K152127 | CorMatrix Tyke | Cormatrix Cardiovascular, Inc. | 2016-02-04 |
| K151865 | PremiPatch PTFE Pledget | Aesculap, Inc. | 2015-10-27 |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch | Synovis Life Technologies, Inc. | 2015-01-07 |
| K142461 | VASCU-GUARD Peripheral Vascular Patch | Synovis Life Technologies, Inc. | 2014-11-25 |
| K140789 | CORMATRIX ECM FOR VASCULAR REPAIR | Cormatrix Cardiovascular, Inc. | 2014-07-15 |
| K130872 | CARDIOCEL | Celxcel Pty, Ltd. | 2014-01-30 |
| K122306 | SYNOVIS COLLAGEN MATRIX (TBD) | Synovis Surgical Innovations | 2013-03-08 |
| K122105 | SMI CARDIOVASCULAR PATCH | Solinas Medical, Inc. | 2012-12-07 |
| K112683 | SMI CARDIOVASCULAR PACH | Solimas Medical, Inc. | 2011-12-14 |
| K111187 | PATCH, PLEDGET AND INTRACARDIAC | Cormatrix Cardiovascular, Inc. | 2011-07-26 |
| K101740 | ALBOSURE POLYESTER VASCULAR PATCH | LeMaitre Vascular, Inc. | 2010-09-20 |
Legacy Summary#
summary
FDA Review#
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