Woven and Knitted Minicrimp Carotid Patch Fabrics
FDA 510(k) K905496 · Meadox Medicals, Div. Boston Scientific Corp.
510(k) numberK905496
Submission
- Device name
- Woven and Knitted Minicrimp Carotid Patch Fabrics
- Applicant
- Meadox Medicals, Div. Boston Scientific Corp.
Oakland, NJ, US - Received
- December 7, 1990
- Decision date
- March 11, 1991
- 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
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| 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 |
|---|---|---|
| K953647 | MS Classique Balloon Catheter W/Hydropass CoatingLIT · Traditional | 05/16/1997SE |
| K960766 | Meadox Medicals, Inc. Expanded PTFE Vascular GraftDYF · Traditional | 03/19/1997ST |
| K962433 | Meadox Exxcel Eptfe Vascular GraftDSY · Traditional | 03/17/1997ST |
| K961847 | Hemashield Vantage (Vascular GraftDSY · Traditional | 01/22/1997ST |
| K962342 | Hemashield Finesse Ultra-Thin, Knitted Cardiovascular PatchDXZ · Traditional | 09/10/1996SE |
| K955460 | Meadox Medicals, Inc., Expanded & Externally Supported Expanded PTFE Vascular GraftDSY · Traditional | 05/30/1996ST |
| K952884 | Noprofile Olbert Catheter System Balloon Dilatation CatheterLIT · Traditional | 02/21/1996SE |
| K955349 | Hemashield Knitted Double Velour Cardiovascular FabricDXZ · Traditional | 02/14/1996SE |
| K953298 | MS Classique Balloon Diatation CatheterLIT · Traditional | 02/08/1996SE |
| K954848 | Hemashield Microvel Velour Knitted Vascular GraftMAL · Traditional | 02/01/1996ST |
Questions and answers
When was Woven and Knitted Minicrimp Carotid Patch Fabrics cleared by the FDA?
Woven and Knitted Minicrimp Carotid Patch Fabrics (K905496) received a 510(k) decision of Substantially Equivalent on March 11, 1991, 94 days after the submission was received.
What is the product code of K905496?
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.