510(k) K240775
- Device
- PeriBeam® Pericardial Membrane
- Applicant
- Tamabio
- 510(k) number
- K240775
- Product code
- DXZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-04-18
- Date received
- 2024-03-21
- 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
- Tetsuya Nagao
- Address
- #402 2-2-18 Sakai Mushashino-Shi Tokyo JP 180-0022 180-0022
FDA Registration Numbers#
- 3017102971
- 1416980
- 1221601
- 1000393132
- 3005636544
- 3002924436
- 2020394
- 1063481
- 3018094310
- 1047843
- 1526611
- 3041851334
- 2648650
- 1060680
- 9680759
- 3019716369
- 1018470
- 2210968
- 1649139
- 3003639970
- 3011137372
- 3002719998
- 1018233
- 1614993
- 3010452421
- 9612515
- 1640201
- 1220948
- 3005064037
- 1450662
- 3009672666
- 1647149
- 3031160994
- 3010041511
- 3006638824
- 3010407203
- 3007791599
- 3004365956
- 9612501
- 2024024
- 1054241
- 3006017180
- 3007284313
- 1043214
- 1282497
- 1055236
- 1835959
- 2320762
- 3010097171
- 2015691
- 2183620
- 3010162973
- 3006082230
- 3004681519
- 3005381997
Source Documents#
Other 510(k) Records For Product Code DXZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K101866 | CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH | Cryolife, Inc. | 2010-07-23 |