Edwards Bovine Pericardial Patch, Model 4700
FDA 510(k) K082139 · Edwards Lifesciences, LLC
510(k) numberK082139
Submission
- Device name
- Edwards Bovine Pericardial Patch, Model 4700
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- July 29, 2008
- Decision date
- October 23, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
Other 510(k)s with product code DXZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240775 | PeriBeam® Pericardial MembraneDXZ · Traditional | Tamabio | 04/18/2025SE |
| K200955 | Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchDXZ · Traditional | Vascutek, Ltd. | 07/08/2020SE |
| K162506 | PhotoFix Decellularized Bovine PericardiumDXZ · Traditional | Cryolife, Inc. | 03/09/2017SE |
| K162579 | VascuCelDXZ · Special | Admedus Regen Pty, Ltd. | 10/14/2016SE |
| K152127 | CorMatrix TykeDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 02/04/2016SE |
| K151865 | PremiPatch PTFE PledgetDXZ · Traditional | Aesculap, Inc. | 10/27/2015SE |
| K142447 | PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 01/07/2015SE |
| K142461 | VASCU-GUARD Peripheral Vascular PatchDXZ · Traditional | Synovis Life Technologies, Inc. | 11/25/2014SE |
| K140789 | Cormatrix Ecm for Vascular RepairDXZ · Traditional | Cormatrix Cardiovascular, Inc. | 07/15/2014SE |
| K130872 | CardiocelDXZ · Traditional | Celxcel Pty, Ltd. | 01/30/2014SE |
More from Celxcel Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…PZX · Traditional | 06/26/2026SE |
| K251326 | Respiration Rate algorithmBZQ · Traditional | 06/11/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | 06/05/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | 04/17/2026SE |
| K253186 | HemoSphere Nano Monitor (HSNANO1)DQK · Traditional | 02/24/2026SE |
| K252533 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)DQK · Traditional | 12/18/2025SE |
| K253034 | HemoSphere Stream ModuleDQK · Special | 10/21/2025SE |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated | 09/23/2025SE |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated | 09/17/2025SE |
| K252364 | Edwards eSheath Optima introducer setDYB · Special | 08/29/2025SE |
Questions and answers
When was Edwards Bovine Pericardial Patch, Model 4700 cleared by the FDA?
Edwards Bovine Pericardial Patch, Model 4700 (K082139) received a 510(k) decision of Substantially Equivalent on October 23, 2008, 86 days after the submission was received.
What is the product code of K082139?
The FDA product code is DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 870.3470.