Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16

Q: What is the product code of K031948?

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) K031948 · Pm Devices, Inc.

Substantially Equivalent

510(k) numberK031948

Submission

Device name: Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16
Applicant: Pm Devices, Inc.
Richmond, Bc, CA
Received: June 24, 2003
Decision date: September 16, 2003
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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

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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
K063556	Peripatch Endo-SleeveFTM · Traditional	03/20/2007SE
K040835	Peripatch Sheet, Models 1.5P8, 1.5P16, 4P4, 4P6, 6P8 and 10P16FTM · Traditional	06/15/2004SE
K033985	Peripatch Sleeve, Models G35, E35, G45, E45, G60, E60, 5C6, 5C8, 5C10FTM · Traditional	06/04/2004SE

Questions and answers

When was Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 cleared by the FDA?

Peripatch Sheet, Models 1.5P8, 4P4, 4P6, 6P8, 10P16, 1.5P16 (K031948) received a 510(k) decision of Substantially Equivalent on September 16, 2003, 84 days after the submission was received.

What is the product code of K031948?

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.