VASCUTEK VASCULAR PROTHESIS VP1200K/50K

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Vascutek Vascular Prothesis Vp1200k/50k.

Pre-market Notification Details

• Device ID: K830016
• 510k Number: K830016
• Device Name: VASCUTEK VASCULAR PROTHESIS VP1200K/50K
• Classification: Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
• Applicant: PACESETTER SYSTEMS 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: DSY
• CFR Regulation Number: 870.3450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-01-03
• Decision Date: 1983-12-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05037881020495	K830016	000
05037881020488	K830016	000
05037881020471	K830016	000