Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible

Q: What is the product code of K963368?

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.

FDA 510(k) K963368 · Glycar, Inc.

Substantially Equivalent

510(k) numberK963368

Submission

Device name: Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible
Applicant: Glycar, Inc.
Dallas, TX, US
Received: August 27, 1996
Decision date: October 31, 1997
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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
K963967	Glycar Pericardial PatchDXZ · Traditional	10/31/1997SE
K963175	Glycar Tissue Repair Patch, Bio-Patch, Uro-SlingFTM · Traditional	09/23/1996SE
K954665	Glycar Staple StripsFTL · Traditional	02/14/1996SE
K942911	Glycar Tissue Repair PatchFTL · Traditional	12/14/1994SE

Questions and answers

When was Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible cleared by the FDA?

Glycartissue Repair Patch Family of Products; Glycar Vascular Repair Patch Alternative Proprietary Name Possible (K963368) received a 510(k) decision of Substantially Equivalent on October 31, 1997, 430 days after the submission was received.

What is the product code of K963368?

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.