PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S

Port & Catheter, Implanted, Subcutaneous, Intravascular

PHARMACIA DELTEC, INC.

The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Port-a-cath Dual Lumen Implantable Venous Access S.

Pre-market Notification Details

• Device ID: K932095
• 510k Number: K932095
• Device Name: PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
• Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular
• Applicant: PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112
• Contact: David H Short
• Correspondent: David H Short; PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112
• Product Code: LJT
• CFR Regulation Number: 880.5965 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-04-30
• Decision Date: 1994-01-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10610586024481	K932095	000
10610586023873	K932095	000