PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER

Port & Catheter, Implanted, Subcutaneous, Intravascular

SIMS DELTEC, INC.

The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Proport Plastic Venous Implantable Access Systems Pre-assembled With Silicone Catheter.

Pre-market Notification Details

• Device ID: K010426
• 510k Number: K010426
• Device Name: PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS PRE-ASSEMBLED WITH SILICONE CATHETER
• Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular
• Applicant: SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112
• Contact: Lisa J Stone
• Correspondent: Lisa J Stone; SIMS 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: 2001-02-13
• Decision Date: 2001-03-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00610586012627	K010426	000
10610586012860	K010426	000
10610586012846	K010426	000
10610586012600	K010426	000