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FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

POWERPORT CLEARVUE SLIM IMPLANTABLE PORT

K Number: K122899 · Decision Nov 15, 2012

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Classifications

FEI Numbers

Registration Numbers

Same Product Code

287

Applicant Total

645

Review Days

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Basic Information

Device Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT
K Number: K122899
Device Class: FDA class 2
Clearance Type: Traditional
Regulation Number: 880.5965
Medical Specialty: General Hospital
Decision: Substantially Equivalent
Statement or Summary: Summary
Applicant: C.R. Bard, Inc.
Date Received: September 21, 2012
Decision Date: November 15, 2012
Product Code: LJT
Advisory Committee: General Hospital
Review Advisory Committee: HO
Third Party: N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	FDA class 2	General Hospital

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