Chase Cardiovascular Patch Kit
FDA 510(k) K020132 · Chase Medical, Inc.
510(k) numberK020132
Submission
- Device name
- Chase Cardiovascular Patch Kit
- Applicant
- Chase Medical, Inc.
Richardson, TX, US - Received
- January 15, 2002
- Decision date
- February 26, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K072473 | Chase MR SystemLNH · Traditional | 12/10/2007SE |
| K062031 | Chase Cardiac Analysis SystemLLZ · Traditional | 09/27/2006SE |
| K032531 | Chase Cardiac Analysis SystemLLZ · Traditional | 02/02/2004SE |
| K022093 | Chase Cardiovascular Patch KitDXZ · Traditional | 09/20/2002SE |
| K021129 | Chare Cariovascular PatchDXZ · Traditional | 06/03/2002SE |
| K020233 | Chase Cardiovascular Patch KitDXZ · Traditional | 03/14/2002SE |
| K012248 | Chase Cardiovascular PatchDXZ · Traditional | 08/10/2001SE |
| K003467 | Chase Cardiovascular PatchDXZ · Traditional | 01/29/2001SE |
| K001662 | Chase Cardiovascular PatchDXZ · Traditional | 08/02/2000SE |
| K972993 | Chase Femoral Access Cannulation SetDWF · Traditional | 03/31/1998SE |
Questions and answers
When was Chase Cardiovascular Patch Kit cleared by the FDA?
Chase Cardiovascular Patch Kit (K020132) received a 510(k) decision of Substantially Equivalent on February 26, 2002, 42 days after the submission was received.
What is the product code of K020132?
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.