Cleared Traditional

K163001 - PowerFlow Apheresis I.V. Port

K163001 is an FDA 510(k) clearance for PowerFlow Apheresis I.V. Port, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code PTD cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K163001 · C.R. Bard, Inc. · General Hospital
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Apr 2017
Decision
171d
Days
Class 2
Risk

K163001 is an FDA 510(k) clearance for the PowerFlow Apheresis I.V. Port. Classified as Subcutaneous Implanted Apheresis Port (product code PTD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on April 17, 2017 after a review of 171 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K163001

510(k) Number K163001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date April 17, 2017
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 129d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PTD Device Classification - Class 2, Special Controls

Product Code PTD Subcutaneous Implanted Apheresis Port
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
Definition A Subcutaneous Implanted Apheresis Port Is A Prescription Device Intended For Patient Therapies Requiring Repeated Access To The Vascular System And Long-term Therapeutic Apheresis
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.