P-S MEDICAL VENTRICULAR ACCESS PORT

Port & Catheter, Implanted, Subcutaneous, Intraventricular

PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for P-s Medical Ventricular Access Port.

Pre-market Notification Details

• Device ID: K874468
• 510k Number: K874468
• Device Name: P-S MEDICAL VENTRICULAR ACCESS PORT
• Classification: Port & Catheter, Implanted, Subcutaneous, Intraventricular
• Applicant: PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118
• Contact: Stephen W Laguette
• Correspondent: Stephen W Laguette; PUDENZ-SCHULTE MEDICAL RESEARCH CORP. P.O. BOX 2090 Goleta, CA 93118
• Product Code: LKG
• CFR Regulation Number: 882.5550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-11-02
• Decision Date: 1988-02-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169497108	K874468	000
00643169496927	K874468	000
00673978228266	K874468	000
00763000030292	K874468	000
00763000030155	K874468	000