Ochsner & Micron Fabric Patch
FDA 510(k) K881508 · Intervascular, Inc.
510(k) numberK881508
Submission
- Device name
- Ochsner & Micron Fabric Patch
- Applicant
- Intervascular, Inc.
Clearwater, FL, US - Received
- April 11, 1988
- Decision date
- May 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K103347 | Cardioroot Woven Collagen Coated Vascular ProsthesesDSY · Special | 02/02/2011SE |
| K042984 | Intergard Woven Connector Graft, Model IGW0030-10CDWF · Traditional | 02/18/2005SE |
| K022242 | Intervascular Intergard Knitted Vascular Graft SizerDSY · Traditional | 08/14/2002SE |
| K013651 | Intergard Hemabridge Collagen Coated Vascular Prosthesis, Intergard Aortic Arch Collagen…DSY · Traditional | 02/27/2002SE |
| K990800 | Intergard Knitted Ultra Thin and Intergard Knitted Collagen Coated and Heparin Bonded…DSY · Traditional | 01/08/2001SE |
| K984294 | Modification of Intergard Woven Collagen Coated Vascular ProsthesesDSY · Traditional | 02/22/1999SE |
| K983819 | Intergard Knitted Ultra Thin Collagen Coated Vascular Graft and Hemacarotid Patch Ultra…DSY · Special | 11/24/1998SE |
| K970843 | Intergard Woven Collagen Coated Vascular ProsthesesDSY · Traditional | 06/05/1997ST |
| K964625 | Hemapatch Vascular Patches, Intergard and Intergard-Rs Vascular ProsthesesDSY · Traditional | 05/05/1997ST |
| K921659 | Ultra Low Porosity Dacron Woven PatchDXZ · Traditional | 11/25/1992SESP |
Questions and answers
When was Ochsner & Micron Fabric Patch cleared by the FDA?
Ochsner & Micron Fabric Patch (K881508) received a 510(k) decision of Substantially Equivalent on May 25, 1988, 44 days after the submission was received.
What is the product code of K881508?
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.