Shelhigh No-React Vascupatch
FDA 510(k) K982810 · Shelhigh, Inc.
510(k) numberK982810
Submission
- Device name
- Shelhigh No-React Vascupatch
- Applicant
- Shelhigh, Inc.
Millburn, NJ, US - Received
- August 11, 1998
- Decision date
- October 28, 1998
- 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
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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 |
|---|---|---|
| K032893 | Shelhigh No-React BiocuffFTL · Traditional | 12/19/2003SE |
| K023940 | Shelhigh BioringKRH · Traditional | 06/04/2003SE |
| K982101 | Shelhigh No-React Dura ShieldGXQ · Traditional | 05/02/2000SE |
| K991567 | Shelhigh No-React Tissue Repair Patch/Uropatch.FTM · Traditional | 07/14/1999SE |
| K981756 | Shelhigh No-React PneumopledgetsFTL · Traditional | 08/05/1998SE |
| K974914 | Shelhigh No-React Pericardial PatchesDXZ · Traditional | 06/03/1998SE |
| K964467 | Shelhigh Pericardial PatchDXZ · Traditional | 09/23/1997SE |
Questions and answers
When was Shelhigh No-React Vascupatch cleared by the FDA?
Shelhigh No-React Vascupatch (K982810) received a 510(k) decision of Substantially Equivalent on October 28, 1998, 78 days after the submission was received.
What is the product code of K982810?
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.