POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS

Port & Catheter, Implanted, Subcutaneous, Intravascular

SMITHS MEDICAL MD, INC.

The following data is part of a premarket notification filed by Smiths Medical Md, Inc. with the FDA for Power Port-a-cath, Cath Ii, And P.a.s. Port T2 Power P.a.c. Implantable Venous Access Systems And Power Gripper Plus.

Pre-market Notification Details

• Device ID: K072657
• 510k Number: K072657
• Device Name: POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS
• Classification: Port & Catheter, Implanted, Subcutaneous, Intravascular
• Applicant: SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, MN 55112
• Contact: Brian Haugstad
• Correspondent: Brian Haugstad; SMITHS MEDICAL MD, INC. 1265 GREY FOX RD. Arden Hills, 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: 2007-09-20
• Decision Date: 2007-12-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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10610586030826	K072657	000
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